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Ajanta Pharma Ltd.

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Check the batch codes below. If yours matches, return it for a refund rather than take it.

Class II

  • May cause temporary or medically reversible harm. Serious consequences are unlikely.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check your batch Filed 2026-05-13

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.

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

Check these codes: Lot#: PA10734, Exp. Jun 2026.

117,168 packs · distributed nationwide within u.s Recall D-0516-2026 on FDA.gov ↗
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