Amneal Pharmaceuticals, LLC Provisional

Bridgewater, NJ · united states

11 recall flag(s), 3 Class I

FDA Flags (11)

Class III RecallJun 2026
Amneal Pharmaceuticals, LLC
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral
Classification: Class III
Class II RecallApr 2026
Amneal Pharmaceuticals, LLC
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Lt
Classification: Class II
Class I RecallApr 2026
Amneal Pharmaceuticals, LLC
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags
Classification: Class I
Class II RecallSep 2025
Amneal Pharmaceuticals, LLC
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pv
Classification: Class II
Class II RecallSep 2025
Amneal Pharmaceuticals, LLC
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals P
Classification: Class II
Class II RecallSep 2025
Amneal Pharmaceuticals, LLC
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pv
Classification: Class II
Class II RecallSep 2025
Amneal Pharmaceuticals, LLC
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, N
Classification: Class II
Class II RecallSep 2025
Amneal Pharmaceuticals, LLC
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt
Classification: Class II
Class I RecallJun 2025
Amneal Pharmaceuticals, LLC
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)
Classification: Class I
Class I RecallMay 2025
Amneal Pharmaceuticals, LLC
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt.
Classification: Class I
Class III RecallAug 2024
Amneal Pharmaceuticals, LLC
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ
Classification: Class III