Recall Firm Index

A no-JavaScript index of recalling firms found in the latest Recall Radar openFDA snapshot. Use it when the firm name is the clue you remember from a label, bottle, notice, or device paperwork. When product or brand text is the stronger clue, use the product clue index. When lot, model, serial, UPC, or expiration text is the stronger clue, use the code clue index. When the FDA problem description is the stronger clue, use the reason clue index. When distribution text is the stronger clue, use the location clue index.

GeneratedSep 23, 2026, 8:30 PM EDT
Firms24
Loaded Records36
Class I Firms6
5 loaded records 1 Class I 5 ongoing Drugs

Baxter Healthcare Corporation

Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield,... | Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Singl... | CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2... | Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Do... | Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total,...

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1 loaded record 1 Class I 1 ongoing Drugs

OPTIMAL BALANCE PHARMACY

Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic...

  • Drugs: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. openFDA source
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4 loaded records 0 Class I 4 ongoing Devices

C.R. Bard Inc

Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 8999... | Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley C... | Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF:... | Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC...

  • Devices: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitten... openFDA source
  • Devices: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitten... openFDA source
  • Devices: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitten... openFDA source
  • Devices: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermitten... openFDA source
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3 loaded records 0 Class I 3 ongoing Devices

Nipro Renal Soultions USA, Corporation

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 | MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)) | Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)

  • Devices: Hemodialysis concentrates contain high endotoxin levels openFDA source
  • Devices: Hemodialysis concentrates contain high endotoxin levels openFDA source
  • Devices: Hemodialysis concentrates contain high endotoxin levels openFDA source
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2 loaded records 0 Class I 2 ongoing Devices

Atrium Medical Corporation

Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016... | Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(1502...

  • Devices: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. openFDA source
  • Devices: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. openFDA source
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2 loaded records 0 Class I 2 ongoing Food

Prince Bakery Inc

Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WH... | Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIE...

  • Food: Sesame is not declared in the ingredient statement but is declared in the statement of identity. openFDA source
  • Food: Sesame is not declared in the ingredient statement but is declared in the statement of identity. openFDA source
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1 loaded record 0 Class I 1 ongoing Drugs

Ajanta Pharma USA Inc

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta P...

  • Drugs: Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term st... openFDA source
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1 loaded record 0 Class I 1 ongoing Devices

Lutronic Corporation

Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delive...

  • Devices: Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentiall... openFDA source
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1 loaded record 0 Class I 1 ongoing Drugs

OurPharma LLC

fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurP...

  • Drugs: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/20... openFDA source
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1 loaded record 0 Class I 1 ongoing Devices

Windstone Medical Packaging, Inc.

AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

  • Devices: The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Pa... openFDA source
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