Major Pharmaceuticals recalls 10-tablet sulfamethoxazole-trimethoprim packs with a foreign microorganism in packaging. No tablets were contaminated. Consumers should check product details and contact the manufacturer for guidance.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Major Pharmaceuticals is recalling a specific type of antibiotic tablets due to a microorganism found in the packaging material. This does not affect the tablets themselves, but the packaging issue could pose a risk if the packaging is compromised.
A microorganism was detected in the auxiliary polyester coil used for packaging. This could potentially contaminate the packaging if it's damaged, but no microorganisms were found on the actual tablets. The risk is low because the tablets themselves are safe.
People who have the specific 10-tablet blister pack with NDC 55154-7895-0 or lot numbers N02309A/B. Those with the antibiotic prescription for urinary tract infections are most at risk if the packaging is damaged.
Check for the product name 'Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets' in a blister pack with NDC 55154-7895-0. Look for lot numbers N02309A or N02309B with expiration dates of 03/31/2027.
Identify the product by checking the NDC code 55154-7895-0 and lot numbers N02309A or N02309B on the packaging.
No microorganisms were detected on the tablets themselves. The issue is with the packaging material.
Check the product details to see if it matches the recalled items. If it does, contact Major Pharmaceuticals for guidance.
The tablets themselves are safe, but the packaging material has a microorganism that could pose a risk if damaged.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0625-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0625-2025 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.