Sulfamethoxazole and Trimethoprim Tablets Recalled for Microbial Contamination
Amneal Pharmaceuticals is recalling Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg) nationwide due to microbial contamination that may cause black spots on tablets. The contamination affects non-sterile products distributed across the USA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is FDA Class I, which per the rubric requires a minimum severity score of 4 ("never go below 4"). Microbial contamination in a non-sterile oral drug product presents risk of serious adverse health consequences.
Plain-English summary
Amneal Pharmaceuticals, LLC is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only. The tablets may exhibit black spots due to microbial contamination of the non-sterile products. Affected bottles include 100-tablet bottles (NDC 65162-271-10) and 500-tablet bottles (NDC 65162-271-50).
The contaminated lots are AM241019, AM241020 (expiration 06/30/2027), and AM241019A (expiration 06/30/2027). Approximately 6,396 bottles were distributed nationwide in the USA by Amneal Pharmaceuticals LLC, Bridgewater, NJ. The tablets were manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India.
Patients who have this medication should contact their healthcare provider or pharmacist. Do not use the recalled tablets without consulting a healthcare professional first. Return the affected medication to the pharmacy where it was dispensed.
The recalled product
- Product
- SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
- Brand
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Prescription Antibiotic
- Hazard
- Affected units
- 6,396
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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