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Amneal Pharmaceuticals, LLC FDA Recalls
11 recalls on file across drugs, 3 of them Class I and 9 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Class IIIJun 3, 2026Cross Contamination with Other Products: due to a potential |
| traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. LtClass IIMar 19, 2026Failed Impurities/Degradation Specifications: N-nitroso-desm |
| Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bagsClass IMar 18, 2026Product mix up: a foil pouch labeled "Magnesium Sulfate in W |
| chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals PClass IIAug 18, 2025Presence of a foreign substance.A specific lot of auxiliary |
| chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals PvtClass IIAug 18, 2025Presence of a foreign substance.A specific lot of auxiliary |
| Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NClass IIAug 18, 2025Presence of a foreign substance.A specific lot of auxiliary |
| chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals PvClass IIAug 18, 2025Presence of a foreign substance.A specific lot of auxiliary |
| chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals PvClass IIAug 18, 2025Presence of a foreign substance.A specific lot of auxiliary |
| Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) Class IJun 2, 2025Microbial contamination of non-sterile products: tablets may |
| Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt.Class IApr 17, 2025Presence of Particulate Matter |
| Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJClass IIIAug 1, 2024Presence of Foreign Tablets: Potential presence of Fludrocor |