These recalled tablets may have visible black spots due to microbial contamination

The FDA has issued a MedWatch email alert to subscribers, stating that Amneal Pharmaceutical LLC is initiating a nationwide recall of three lots of Sulfamethoxazole/Trimethoprim Tablets, USP 400 mg/80 mg, because some tablets may have black spots indicative of microbial contamination.

The discoloration was reported in a product quality complaint, prompting Amneal to coordinate with the FDA and inform health-care professionals, wholesalers, distributors and consumers of the potential safety concern.

The recall due to microbial contamination applies exclusively to three lots of Sulfamethoxazole/Trimethoprim Tablets, USP 400 mg/80 mg, distributed nationwide to wholesalers and distributors between December 4, 2024, and May 15, 2025. The affected lot numbers, packaging configurations and expiration dates are as follows:

• Lot AM241019 (NDC 65162-271-10; expiration June 2027; 100-tablet bottles; first distributed December 4th 2024)
  
• Lot AM241019A (NDC 65162-271-50; expiration 06/2027; 500-tablet bottles; first distributed 12/04/2024)
  
• Lot AM241020 (NDC 65162-271-10; expiration 06/2027; 100-tablet bottles; first distributed 12/04/2024)

No other lots of Sulfamethoxazole/Trimethoprim Tablets, USP 400 mg/80 mg — or any other strength of this drug — are impacted by this recall.

Amneal’s recall notice includes a warning that ingesting oral products contaminated with Aspergillus can lead to severe, potentially life-threatening infections, particularly among patients with weakened immune systems. The company also noted that it has not received any reports of illnesses, injuries or adverse reactions linked to the three affected lots to date.

Sulfamethoxazole/Trimethoprim Tablets, USP 400 mg/80 mg, are approved for the treatment of urinary tract infections caused by susceptible strains of Morganella morganii, Escherichia coli, Enterobacter species, Klebsiella species, Proteus vulgaris and Proteus mirabilis; enteritis caused by susceptible Shigella flexneri strains and traveler’s diarrhea in adults; acute otitis media in pediatric patients and acute exacerbations of chronic bronchitis due to susceptible Streptococcus pneumoniae.

The product is available in bottles of 100 tablets and 500 tablets. This recall affects only the three listed lots of the 400 mg/80 mg strength; no additional strengths or lot numbers are impacted.

Amneal says it is informing customers via UPS and making arrangements for the return of all recalled products. The company also says it is asking distributors and wholesalers to notify their customers and provide instructions on returning the affected tablets to Amneal. Retailers must inform those who have purchased any of the impacted lots and direct them to contact Amneal for return procedures and reimbursement information.

Individuals seeking further details about this recall may reach Amneal Pharmaceutical LLC as follows:

• Phone: 833-582-0812 (Monday – Friday, 8:00 am – 5:00 pm ET)
  
• Fax: 631-983-2595
  
• Email: sulfamethoxazole-trimethoprim-recall@amneal.com.
  For medical inquiries, to report adverse events or to report quality problems, customers can contact Amneal Drug Safety at 1-877-835-5472 (Monday – Friday, 8:00 am – 6:00 pm ET) or via email at DrugSafety@amneal.com.

For medical inquiries or to report any adverse events or quality concerns related to this product, health-care professionals and consumers can contact Amneal Drug Safety at 1-877-835-5472 (Monday–Friday, 8 am–6 pm ET) or via email at DrugSafety@amneal.com. Adverse reactions or product quality issues may also be reported directly to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by submitting an online report, downloading and mailing or sending via fax a form obtained by calling 1-800-332-1088 or sending via fax completed forms to 1-800-FDA-0178.

The FDA says that this recall is being conducted with its knowledge. The FDA published Amneal’s announcement Wednesday.