Drugs
Not Yet Classified
Ongoing
Reported Sep 16, 2026
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
- Firm
- OurPharma LLC
- Codes
- Lot #: 101301260605, BUD: 12/9/2026.
- Reason
- Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Drugs
Class III
Ongoing
Reported Sep 16, 2026
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
- Firm
- Ajanta Pharma USA Inc
- Codes
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Reason
- Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0...
Drugs
Class III
Ongoing
Reported Sep 16, 2026
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 078...
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
- Firm
- ImprimisRx NJ LLC
- Codes
- Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- Reason
- Subpotent Drug
Food
Class I
Ongoing
Reported Sep 16, 2026
Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
- Firm
- International Sprout Holdings, Inc
- Codes
- ISS Lot # SAL2-24JB
- Reason
- Potential E. coli and Salmonella contamination
Drugs
Class I
Ongoing
Reported Sep 16, 2026
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
- Firm
- Baxter Healthcare Corporation
- Codes
- Lot #: Y495066, Exp. Date July 31, 2027
- Reason
- Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Food
Class II
Ongoing
Reported Sep 16, 2026
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
- Firm
- Ferrero USA
- Codes
- All best by codes that were sold 8/7/2026 to 8/14/2026
- Reason
- Undeclared milk and pecans
Food
Class I
Ongoing
Reported Sep 16, 2026
Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, Whit...
Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, White Pepper. Proudly Made in Indonesia. Imported for Exotique Foods, Inc. Toronto, ON - Canada.
- Firm
- EXOTIQUE FOODS CANADA
- Codes
- Best Before: 2026 AUGUST 31
- Reason
- Undeclared Wheat.
Food
Class II
Ongoing
Reported Sep 16, 2026
Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530
Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530
- Firm
- L-Nutra Inc
- Codes
- Lot code: L2755 Expiration: 02 Jan 2027
- Reason
- Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
- Firm
- Atrium Medical Corporation
- Codes
- 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Si...
- Reason
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Firm
- Atrium Medical Corporation
- Codes
- 1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- Reason
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic han...
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser treatment
- Firm
- Lutronic Corporation
- Codes
- Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A01...
- Reason
- Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Devices
Class II
Ongoing
Reported Sep 16, 2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- Firm
- Nipro Renal Soultions USA, Corporation
- Codes
- BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
- Reason
- Hemodialysis concentrates contain high endotoxin levels
Devices
Class II
Ongoing
Reported Sep 16, 2026
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Firm
- Nipro Renal Soultions USA, Corporation
- Codes
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- Reason
- Hemodialysis concentrates contain high endotoxin levels
Devices
Class II
Ongoing
Reported Sep 16, 2026
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
- Firm
- Nipro Renal Soultions USA, Corporation
- Codes
- LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
- Reason
- Hemodialysis concentrates contain high endotoxin levels
Food
Class I
Ongoing
Reported Sep 16, 2026
Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen
Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen
- Firm
- EURO FOODS GROUP USA NJ INC
- Codes
- BATCH NO: 130 EF, 146 EF SERIAL NUMBER: 5055192640140 PRODUCT CODE: 28DSUM
- Reason
- The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying.
Devices
Class II
Ongoing
Reported Sep 16, 2026
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
- Firm
- Windstone Medical Packaging, Inc.
- Codes
- UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444,...
- Reason
- The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the i...
Devices
Class II
Ongoing
Reported Sep 16, 2026
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US...
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 45...
- Firm
- HeartSine Technologies Ltd
- Codes
- 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K...
- Reason
- Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00...
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A8996...
- Firm
- C.R. Bard Inc
- Codes
- Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 0080174102...
- Reason
- Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 008017410...
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300416A UDI code: 00801741073762¿ 10801741073769 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care RE...
- Firm
- C.R. Bard Inc
- Codes
- Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 0080174102...
- Reason
- Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complet...
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Comple...
- Firm
- C.R. Bard Inc
- Codes
- SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A3044...
- Reason
- Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System...
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AMC UDI-DI code: 00801741143472 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800366C UDI-DI code: 00801741143571 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897514C...
- Firm
- C.R. Bard Inc
- Codes
- (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete...
- Reason
- Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Drugs
Class III
Ongoing
Reported Sep 9, 2026
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus P...
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
- Firm
- Supernus Pharmaceuticals, Inc.
- Codes
- Lot# 2145283, Exp Date: 31-Mar-2030.
- Reason
- Failed dissolution specifications.
Drugs
Class II
Ongoing
Reported Sep 9, 2026
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsip...
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
- Firm
- Teva Pharmaceuticals USA, Inc
- Codes
- Lot: 1394026, Exp. 02/2028.
- Reason
- Presence of Foreign Tablets/Capsules
Drugs
Class III
Ongoing
Reported Sep 9, 2026
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual...
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
- Firm
- American Health Packaging
- Codes
- Lot # 1030023, Exp Date: 06/30/2027.
- Reason
- Labeling: Label Mix-up
Food
Class III
Ongoing
Reported Sep 9, 2026
Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVI...
Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED, AND/OR CANOLA OILS) DOUGH CONDITIONER [WHEY MILK], CORN FLOUR, MONOCALCIUM PHOSPHATE, L-CYSTEINE, HYDROCHLORIDE, POTASSIUM BROMATE), DEXTROSE, MONO-DIGLYCERIDES, SUGAR, GUAR GUM, MALT BARLEY FLOUR, ETHOXYLATED MONO-DIGL...
- Firm
- Prince Bakery Inc
- Codes
- No codes
- Reason
- Sesame is not declared in the ingredient statement but is declared in the statement of identity.
Food
Class III
Ongoing
Reported Sep 9, 2026
Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE...
Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED AND/OR CANOLA OILS), DOUGH CONDITIONER [WHEY (MILK), CORN FLOUR, MONOCALCIUM PHOSPHATE, L-CYSTEINE HYDROCHLORIDE, POTASSIUM BROMATE] DEXTROSE, MONO-DIGLCYERIDES, DIACETYL, TARTARIC ACID E...
- Firm
- Prince Bakery Inc
- Codes
- No codes
- Reason
- Sesame is not declared in the ingredient statement but is declared in the statement of identity.
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 600...
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.
- Firm
- Baxter Healthcare Corporation
- Codes
- Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.
- Reason
- CGMP Deviations
Drugs
Class II
Ongoing
Reported Sep 9, 2026
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthc...
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
- Firm
- Baxter Healthcare Corporation
- Codes
- Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
- Reason
- CGMP Deviations
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield...
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
- Firm
- Baxter Healthcare Corporation
- Codes
- Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.
- Reason
- CGMP Deviations
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Co...
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
- Firm
- Baxter Healthcare Corporation
- Codes
- Lot # NC193856, Exp Date: 04/18/2028.
- Reason
- CGMP Deviations
Food
Class II
Ongoing
Reported Sep 9, 2026
Weis (Fresh From the Orchard ) Pasteurized Apple Cider, Contains 100 % Juice, the product comes in the following sizes: Pints, 1/2 Gallon, Gallon, plastic jug. 6 1/2 - gallon jugs...
Weis (Fresh From the Orchard ) Pasteurized Apple Cider, Contains 100 % Juice, the product comes in the following sizes: Pints, 1/2 Gallon, Gallon, plastic jug. 6 1/2 - gallon jugs per crate.
- Firm
- WEIS MARKETS, INC.
- Codes
- pull date/expiration date, etc. 7/17/26, 8/4/26, 8/13/26, 8/28/26, 9/4/26, 9/11/26, 9/30/26
- Reason
- Product has high patulin levels
Drugs
Class I
Ongoing
Reported Sep 9, 2026
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only,...
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
- Firm
- OPTIMAL BALANCE PHARMACY
- Codes
- Lot#: LG342009076, Beyond Use Date: 10/4/26
- Reason
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Food
Class II
Ongoing
Reported Sep 9, 2026
Bread Pudding with Vanilla Sauce - KIT NET WT 4 LB (1.81Kg) UPC 7 22515 91732 0 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Bread Pudding with Vanilla Sauce - KIT NET WT 4 LB (1.81Kg) UPC 7 22515 91732 0 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
- Firm
- Ukrop's Homestyle Foods LLC
- Codes
- Best By 07/06/26 to Best By 08/03/26
- Reason
- Foreign object: metal fragments
Food
Class III
Ongoing
Reported Sep 9, 2026
Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags
Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags
- Firm
- Wonton Specialists
- Codes
- No codes.
- Reason
- Undeclared FD&C Red No. 40
Food
Class III
Ongoing
Reported Sep 9, 2026
Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags
Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags
- Firm
- Wonton Specialists
- Codes
- No codes.
- Reason
- Undeclared FD&C Red No. 40
Food
Class I
Ongoing
Reported Sep 9, 2026
OLA-OLA Pounded Yam (Iyan) IYANINSTANT, NET WT. 2 lbs., 4 lbs., 5 lbs., 10 lbs, packed in flexible plastic bags. INGREDIENTS: Processed Dehydrated Yam Flour, freshness preserved by...
OLA-OLA Pounded Yam (Iyan) IYANINSTANT, NET WT. 2 lbs., 4 lbs., 5 lbs., 10 lbs, packed in flexible plastic bags. INGREDIENTS: Processed Dehydrated Yam Flour, freshness preserved by BHT & sodium bisulfite. UPCs: (2 lb): 650655244825, (4 lb): 650655496873, (5 lb): 650655244856, (10 lb): 650655244702 Manufacturer information is printed on the front label panel: Manufactured by: Yusol International Foods Sacramento CA 95828 www.yusolfood.com. The 10-lb bag is distributed to multiple consignees. The firm erroneously pac...
- Firm
- Fayus Inc.
- Codes
- All batch codes.
- Reason
- Undeclared milk.