Amneal Pharmaceutical LLC Nationwide Recalling Issued as Mysterious Black Spots Trigger Safety Concern in Antibiotic

Bridgewater, NJ — June 2, 2025 — A routine quality check turned into a nationwide safety alert when Amneal Pharmaceutical LLC quietly began recalling certain batches of a commonly used antibiotic—and the culprit? Tiny black specks.

Tiny Dots, Big Alarm

What seemed like a cosmetic defect—black spots on the surface of Sulfamethoxazole/Trimethoprim (400 mg/80 mg) tablets—set off alarm bells. The visible markings, found during a product quality complaint, turned out to be microbial contamination, with the mold Aspergillus as the likely suspect. investors.amneal.comU.S. Food and Drug Administration

Why This Matters

Though no illnesses or adverse effects have been linked to the recall so far, there’s a serious health caveat: oral products tainted with Aspergillus can spark life-threatening infections, especially in patients with weakened immune systems. investors.amneal.comNasdaqCDPH

Only Specific Lots Affected

The recall is tightly targeted: it only concerns the 400 mg/80 mg strength, in 100- and 500-count bottles, and only three specific lots:

• AM241019 (100‑count, exp. 06/2027)
• AM241019A (500‑count, exp. 06/2027)
• AM241020 (100‑count, exp. 06/2027)
  These tablets were distributed nationwide between December 4, 2024, and May 15, 2025. investors.amneal.comNasdaqCDPH

Amneal Takes Action

Responding swiftly, Amneal is notifying pharmacies, distributors, and consumers via UPS and email, and arranging for returns.investors.amneal.comU.S. Food and Drug Administration Patients and retailers are urged to check their medication and return affected products.

Need Help? Here’s Who to Call

If you’re concerned or believe you have one of the recalled bottles, you can reach Amneal at:

• 833‑582‑0812 (Mon–Fri, 8 am–5 pm EST)
• Fax: 631‑983‑2595
• Email: sulfamethoxazole‑trimethoprim‑recall@amneal.com

For medical inquiries or to report any adverse events, contact Amneal Drug Safety at 1‑877‑835‑5472 (Mon–Fri, 8 am–6 pm EST) or via DrugSafety@amneal.com. Reports can also be submitted to the FDA’s MedWatch program. investors.amneal.comOncology Nursing Societyclinicaladvisor.com

What You Should Do

• If you’re using Sulfamethoxazole/Trimethoprim for UTIs, ear infections, bronchitis flares, enteritis, or travelers’ diarrhea, check the lot number and expiration date on your bottle.
• If your product matches any recalled lot, stop using it immediately and follow Amneal’s instructions for return and reimbursement.
• Stay alert: no side effects have been reported yet, but better safe than sorry.