Ajanta Pharma recalls 30mg Duloxetine Delayed-Release Capsules with N-nitroso-Duloxetine impurity above FDA limits. Consumers should check NDC numbers and lot dates for affected batches.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Ajanta Pharma is recalling specific batches of 30mg Duloxetine Delayed-Release Capsules due to a harmful chemical impurity found in some products. This impurity could pose a health risk if taken by people who need the medication.
The recall involves a chemical impurity called N-nitroso-Duloxetine that was found in higher levels than the FDA allows. This impurity could potentially cause health issues if the medication is taken as directed.
People prescribed Duloxetine by a doctor who have the recalled batch numbers. Those taking the medication for depression, nerve pain, or other conditions are most at risk.
Check the product label for NDC numbers: 27241-098-09 (90 capsules), 27241-098-03 (30 capsules), or 27241-098-10 (1000 capsules). Also check the lot number and expiration date on the packaging.
Look for the NDC numbers 27241-098-09, 27241-098-03, or 27241-098-10 on the packaging.
The recall is due to the presence of N-nitroso-Duloxetine impurity above the FDA's recommended limit of 0.83 ppm, found during stability testing.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates the impurity could pose health risks, but the specific risks are not detailed in the official notice.
We’ve drafted a message you can send Ajanta Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0514-2026 — Ajanta Pharma Ajanta Pharma Hello, I own a Ajanta Pharma that is covered by recall D-0514-2026 from Ajanta Pharma. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
