FDA Drugs recall ·
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0488-2025
- Date
- (initiated June 2, 2025)
- Company / brand
- Amneal Pharmaceuticals, LLC
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 6396 bottles
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0488-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.