Ajanta Pharma USA recalls 60mg Duloxetine capsules (NDC 27241-099-03) with N-nitroso impurity above FDA limits. Consumers should 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 60mg Duloxetine Delayed-Release Capsules (30-count) 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 exceeding 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', 60 mg, 30 capsules, NDC 272:241-099-03, Lot# PA07434, Exp. May 2026. The product was made in India and marketed by Ajanta Pharma USA Inc.
Reach out to Ajanta Pharma USA Inc. for specific instructions on handling the recalled product.
The product contains N-nitroso-Duloxetine impurity above FDA limits, but the risk level is considered low. Consult your healthcare provider for personalized advice.
Look for the NDC 27241-099-03, Lot# PA07434, and expiration date of May 2026 on the product label.
Contact Ajanta Pharma USA Inc. for specific instructions on handling the recalled product.
We’ve drafted a message you can send Ajanta Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0515-2026 — Ajanta Pharma Ajanta Pharma Hello, I own a Ajanta Pharma that is covered by recall D-0515-2026 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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