D-0488-2025 Class I Ongoing
FDA drug recall D-0488-2025 was initiated by Amneal Pharmaceuticals, LLC on June 2, 2025 and is designated Class I. Reason for recall: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. The recall status is ongoing. Affected quantity: 6396 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2025
- Initiation Date
- June 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6396 bottles
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.
Reason for Recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027