Antibiotic Tablets Recalled Nationwide for Microbial Contamination
Amneal Pharmaceuticals is recalling Sulfamethoxazole and Trimethoprim tablets nationwide due to microbial contamination. Affected tablets may display black spots.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, the agency's most serious classification. Although no illnesses or deaths have been reported in the source text, the potential for microbial contamination of an oral antibiotic drug meets the threshold for Severe classification.
Plain-English summary
Amneal Pharmaceuticals, LLC, is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, due to microbial contamination of the product. Tablets may exhibit black spots as a sign of contamination.
The affected product was distributed nationwide in the United States. The recall involves 6,396 bottles in two package sizes: 100-tablet bottles (NDC 65162-271-10) and 500-tablet bottles (NDC 65162-271-50). The affected lot numbers are AM241019, AM241020, and AM241019A, all expiring June 30, 2027.
Patients currently taking this medication should contact their healthcare provider or pharmacist immediately. Do not use affected bottles. Consumers should return the medication to their pharmacy or contact Amneal Pharmaceuticals for instructions on disposal or replacement.
The recalled product
- Product
- SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
- Brand
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug
- Hazard
- microbial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: a) AM241019
- AM241020
- Exp. 06/30/2027 b) AM241019A
- Exp 06/30/2027
UPCs (2)
- 0365168211102
- 0365162272109
Distribution
Distributed nationwide across the United States.
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