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Voluntary nationwide recall: Sulfamethoxazole/Trimethoprim (Amneal – June)
UPMC Health Plan·Pharmacy, Infectious Disease, Internal Medicine +3 more·Pharmacy
Effective date
Jun 2, 2025
We identified it
Aug 7, 2026
Summary
Amneal Pharmaceutical LLC is recalling specific lots of Sulfamethoxazole/Trimethoprim (400 mg/80 mg) tablets due to microbial contamination causing black spots. Affected patients should stop using the product immediately and return it to Amneal. Billing teams must be aware that patients may request medication substitutions or encounter treatment delays related to this recall.
Action Required
Immediately: Notify all clinical staff and providers of this voluntary recall. Establish a process to identify patients currently prescribed affected Amneal Sulfamethoxazole/Trimethoprim lots (contact Amneal at 833-582-0812 or check FDA website for lot numbers). When affected patients are identified: (1) Alert providers to prescribe alternative antibiotics; (2) Flag claims in billing system that reference this medication to ensure proper substitution coding; (3) Be prepared to process claims for alternative antibiotic therapy at potentially different reimbursement rates. Document all medication switches in patient records and ensure accurate coding of replacement prescriptions. No claims should be denied due to medication substitution related to this recall. Communicate with patients' pharmacies to confirm they do not dispense recalled lots.