Class I
Ongoing
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.
This recall is currently active, issued June 18, 2025. It was issued by Amneal Pharmaceuticals, Llc.
- Company
- Amneal Pharmaceuticals, Llc
- Recall Initiated
- June 2, 2025
- Posted
- June 18, 2025
- Recall Number
- D-0488-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6396 bottles
- Firm Location
- Bridgewater, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
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