Major Pharmaceuticals recalls 20mg Duloxetine capsules due to potential nitrosamine impurities. This could pose health risks if consumed. Affected lots: N01530 (exp 01/2025) and N01540 (exp 01/2025).
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Major Pharmaceuticals is recalling 20mg Duloxetine Delayed-Release Capsules that may contain unsafe levels of nitrosamine impurities. This could pose health risks if taken as directed. The recall affects specific lot numbers with expiration dates in January 2025.
The capsules may contain nitrosamine impurities above FDA safety limits. Nitrosamines are known carcinogens that can increase cancer risk with long-term exposure. However, the exact health risk from this specific impurity level is not clearly stated in the recall.
People who have the recalled lot numbers (N01530 or N01540) with expiration dates of January 2025. Prescriptions for this medication are typically for those with depression or back pain.
Check the blister pack for lot number N01530 (expiring 01/2025) or N01540 (expiring 01/2025). The product is a prescription-only 20mg Duloxetine capsule.
Look for the lot number on the blister pack: N01530 or N01540 with expiration date January 2025.
The recall states there may be unsafe levels of nitrosamine impurities, but the exact health risk is not clearly described. Consult your doctor for advice.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
Check the blister pack for lot number N01530 (expiring 01/2025) or N01540 (expiring 01/2025).
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0212-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0212-2025 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.
