Ajanta Pharma USA recalls 20mg Duloxetine capsules (NDC 27241-097-06) for potential N-nitroso impurity above FDA limits. Consumers should check lot numbers and contact for details.
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 20mg Duloxetine Delayed-Release Capsules due to a chemical impurity found during stability testing. This impurity could pose a health risk if consumed in quantities above the FDA's safety limit.
The capsules contain N-nitroso-Duloxetine impurity levels above the FDA's recommended limit of 0.83 ppm. This impurity was detected during long-term stability testing at 12 and 18 months.
Prescription patients using the recalled Duloxetine capsules. Those with specific medical conditions requiring this medication may be at higher risk.
Check for the product name 'Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules' with lot number PA10734 and expiration date June 2026.
Verify the lot number PA10734 and expiration date June 2026 on the packaging.
The recall is for potential impurity levels above FDA limits, but the product is not considered unsafe for immediate use. Check the lot number and contact the manufacturer for details.
The recall record does not specify a replacement process or remedy.
The recall record does not specify a remedy, so contact Ajanta Pharma USA for guidance.
We’ve drafted a message you can send Ajanta Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0516-2026 — Ajanta Pharma Ajanta Pharma Hello, I own a Ajanta Pharma that is covered by recall D-0516-2026 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.
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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.
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