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.
Reported: June 18, 2025 Initiated: June 2, 2025 #D-0488-2025
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.
Details
- Recalling Firm
- Amneal Pharmaceuticals, LLC
- Units Affected
- 6396 bottles
- Distribution
- Nationwide in the USA
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Amneal Pharmaceuticals, LLC. Units affected: 6396 bottles.
Why was this product recalled? ▼
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 18, 2025. Severity: Critical. Recall number: D-0488-2025.
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