Drug recalls
Drug recall enforcement reports: the product, the firm, the reason and the recall class. 17,975 records; openFDA updated it 2026-09-25. About this dataset
Newest records
- Class II14,511
- Class I1,747
- Class III1,715
- Not Yet Classified2
- 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,…
OurPharma LLC · 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…
- Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made…
Ajanta Pharma USA Inc · Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.…
- Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
Baxter Healthcare Corporation · Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
- 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 · CGMP Deviations
- Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter H…
Baxter Healthcare Corporation · CGMP Deviations
- 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, S…
Baxter Healthcare Corporation · CGMP Deviations
- Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for inj…
OPTIMAL BALANCE PHARMACY · Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Man…
Baxter Healthcare Corporation · CGMP Deviations
- Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, K…
Supernus Pharmaceuticals, Inc. · Failed dissolution specifications.
- Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217…
American Health Packaging · Labeling: Label Mix-up
- traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manuf…
Teva Pharmaceuticals USA, Inc · Presence of Foreign Tablets/Capsules
- 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL…
Baxter Healthcare Corporation · Presence of particulate matter: Particulates identified as fiberglass
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single us…
Allies Group Inc. · Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the…
Allies Group Inc. · Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx onl…
Baxter Healthcare Corporation · CGMP Deviations
- Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe…
Lexia LLC · CGMP Deviations: Potential contamination of raw material
- Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton),…
Baxter Healthcare Corporation · CGMP Deviations
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextr…
Baxter Healthcare Corporation · CGMP Deviations
- Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic,…
Baxter Healthcare Corporation · CGMP Deviations
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.