What’s Being Recalled?
On June 2, 2025, Amneal Pharmaceutical LLC initiated a nationwide recall of three specific lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, due to microbial contamination. Tablets from the affected lots may display black spots, identified as Aspergillus, a potentially harmful fungus. This recall only applies to two pack sizes—100-count and 500-count bottles—and specifically to the 400 mg/80 mg strength. U.S. Food and Drug AdministrationAVMAFierce Pharma
The Risk: Why It Matters
Aspergillus contamination is no trivial matter—ingesting contaminated oral antibiotics can lead to serious, even life-threatening infections, particularly in individuals with weakened immune systems. Luckily, as of early June 2025, no adverse health events have been reported in connection with this recall. U.S. Food and Drug AdministrationCDPH
Affected Lots & Distribution Details
Only the following three lots are impacted:
- AM241019 (100-tablet bottle; NDC 65162-271-10; Expiration: June 2027; Initial distribution: December 4, 2024)
- AM241019A (500-tablet bottle; NDC 65162-271-50; Expiration: June 2027; Initial distribution: December 4, 2024)
- AM241020 (100-tablet bottle; NDC 65162-271-10; Expiration: June 2027; Initial distribution: December 4, 2024) U.S. Food and Drug AdministrationAVMA
All affected units were distributed domestically between December 4, 2024 and May 15, 2025, and include only the specified 400 mg/80 mg tablets. U.S. Food and Drug AdministrationCDPH
Therapeutic Uses of the Medication
Sulfamethoxazole/Trimethoprim (commonly known as co-trimoxazole) is widely used to treat a variety of bacterial infections, such as:
- Urinary tract infections (e.g., E. coli, Klebsiella, Proteus)
- Acute otitis media in children
- Acute exacerbations of chronic bronchitis
- Enteritis due to Shigella and traveler’s diarrhea in adults U.S. Food and Drug AdministrationOncology Nursing Society
Steps Being Taken
Amneal is:
- Notifying wholesalers, distributors, and retailers—facilitated via UPS—about the recall.
- Organizing the return and reimbursement of all recalled products.
- Advising consumers to contact Amneal directly for instructions on returning the medication and obtaining refunds. U.S. Food and Drug AdministrationPrime Therapeutics
Contact Information for Consumers:
- Phone: 1-833-582-0812 (Mon–Fri, 8 am–5 pm ET)
- Email: sulfamethoxazole-trimethoprim-recall@amneal.com U.S. Food and Drug AdministrationPrime Therapeutics
Reporting Concerns or Adverse Events
Healthcare professionals and consumers should report any quality issues or adverse effects to Amneal’s Drug Safety team:
- Phone: 1-877-835-5472 (Mon–Fri, 8 am–6 pm ET)
- Email: DrugSafety@amneal.com
Alternatively, reports can be submitted to the FDA’s MedWatch program online, by mail, or by fax. U.S. Food and Drug AdministrationPrime Therapeutics
Industry & Clinical Response
- Humana, among other health systems, has alerted providers to review their patient records and contact those prescribed the recalled medication. Humana
- Community pharmacy boards, like California’s, have urged pharmacies to refresh their recall procedures and assess whether corrective actions are needed. California State Board of PharmacyCDPH
- Industry coverage, including analysis by Fierce Pharma, highlights Amneal’s repeated recall incidents, including prior vancomycin and ropivacaine recalls earlier in 2025. Fierce Pharma
Summary Table
| Aspect | Details |
|---|---|
| Product | Sulfamethoxazole/Trimethoprim 400 mg/80 mg tablets (AM241019, AM241019A, AM241020) |
| Issue | Microbial contamination (Aspergillus – black spots on tablets) |
| Distribution | Nationwide, Dec 4, 2024 – May 15, 2025; Expiry: June 2027 |
| Risk | Potentially life-threatening infections, especially in immunocompromised patients |
| Action Required | Return medication; reimbursement available; no use of affected lots |
| Reporting | Amneal Drug Safety; FDA MedWatch |
| Affected Parties | Patients, pharmacies, wholesalers, and healthcare providers |
Bottom Line:
This recall reflects an important safety precaution—Aspergillus contamination in an oral antibiotic is rare but serious. Swift action from Amneal is critical to prevent adverse outcomes, especially for vulnerable patient populations. If you’re taking—or prescribing—this medication, double-check lot numbers and cease use immediately if they match the recalled ones. And regardless of how minor it seems, report any concerns to help safeguard public health.
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