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.
Firm: OurPharma LLC
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).
openFDA source record
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.
Firm: Ajanta Pharma USA Inc
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 percent.
openFDA source record
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...
Firm: ImprimisRx NJ LLC
Reason: Subpotent Drug
openFDA source record
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
Firm: International Sprout Holdings, Inc
Reason: Potential E. coli and Salmonella contamination
openFDA source record
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
Firm: Baxter Healthcare Corporation
Reason: Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
openFDA source record
Food
Class II
Ongoing
Reported Sep 16, 2026
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Firm: Ferrero USA
Reason: Undeclared milk and pecans
openFDA source record