Amneal Pharmaceuticals, LLC

7 recalls on record

Class II2025-09-10

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Amneal Pharmaceuticals, LLCdrug

Class II2025-09-10

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Amneal Pharmaceuticals, LLCdrug

Class II2025-09-10

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Amneal Pharmaceuticals, LLCdrug

Class II2025-09-10

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Amneal Pharmaceuticals, LLCdrug

Class II2025-09-10

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Amneal Pharmaceuticals, LLCdrug

Class I — Urgent2025-06-18

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Amneal Pharmaceuticals, LLCdrug

Class I — Urgent2025-05-14

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)

Presence of Particulate Matter

Amneal Pharmaceuticals, LLCdrug