Amneal Pharmaceuticals, LLC: Drug Recall

Recall Details

Recall Number

D-0488-2025

Classification

Class I

Product Type

Drug

Recalling Firm

Amneal Pharmaceuticals, LLC

Status

Ongoing

Date Initiated

06/02/2025

Location

Bridgewater, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6396 bottles

Reason for Recall

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

Product Description

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Amneal Pharmaceuticals, LLC

• Class II: Risk 08/18/2025
  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.
• Class II: Risk 08/18/2025
  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.
• Class II: Risk 08/18/2025
  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.
• Class II: Risk 08/18/2025
  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.
• Class II: Risk 08/18/2025
  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.

View all recalls by Amneal Pharmaceuticals, LLC →