Drug recall
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC…
FDA recall event 96985 · Class I · Amneal Pharmaceuticals, LLC
Key facts
| Event ID | 96985 |
|---|---|
| Recall numbers | D-0488-2025 |
| Recalling firm | Amneal Pharmaceuticals, LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. |
| Initiation date | Jun 2, 2025 |
| Report date | Jun 18, 2025 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3012625281 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: