Recalls & safety alerts
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Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg
Date issued
Brand
AmnealLot code/Notes
Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination.The recalled product was distributed nationwide to wholesalers/distributors between the dates of 12/4/2024 to 5/15/2025 only.
Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg is packaged in 100 tablet count and 500 tablet count bottles. This recall pertains only to the 400 mg/80 mg strength and only to the listed Lots below. The lot number can be found on the Amneal bottle label or consult your pharmacy if you received a pharmacy vial. No other Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg lots are impacted.
Lot Numbers and NDC Numbers with expiration dates and distribution dates:
100 Count: Lot AM241019; NDC 65162-271-10; Expiration: 06/2027; First Distribution Date: 12/4/2024
500 Count: Lot AM241019A; NDC 65162-271-50; Expiration: 06/2027; First Distribution Date: 12/4/2024
100 Count: Lot AM241020; NDC 65162-271-10; Expiration: 06/2027; First Distribution Date: 12/4/2024
Reason
Microbial contamination