Sulfamethoxazole/Trimethoprim Tablets recalled due to Microbial contamination, USA

United States

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 observance of black spots was reported in a product quality complaint. The recalled product was distributed nationwide to wholesalers/distributors between the dates of 12/4/2024 to 5/15/2025 only.

Risk Statement: Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.

The product is indicated for the treatment of Urinary tract infections caused by susceptible strains of the following organisms: Escherichia Coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris.  Acute otitis media in pediatric patients. Acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae. Enteritis caused by susceptible strains of Shigella flexneri and traveler's diarrhea in adults. 

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.

AFFECTED PRODUCTS:

- Lot Number: AM241019
- NDC Number: 65162-271-10
- Expiration Date: 06/2027
- Date of First Distribution: 12/4/2024
- Bottle Pack Size: 100 count

- Lot Number: AM241019A
- NDC Number: 65162-271-50
- Expiration Date: 06/2027
- Date of First Distribution: 12/4/2024
- Bottle Pack Size: 500 count

- Lot Number: AM241020
- NDC Number: 65162-271-10
- Expiration Date: 06/2027
- Date of First Distribution: 12/4/2024
- Bottle Pack Size: 100 count

If you are experiencing symptoms after eating this product, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical attention.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400