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Drug FDA Class II Ongoing cGMP deviation

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

Ajanta Pharma Ltd. Published May 13, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Ajanta Pharma Ltd. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

N-nitroso-duloxetine · primary

Affected products (1)

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

DULOXETINE · 312,894 packs

NDC: 27241-097, 27241-098, 27241-164, 27241-099, 27241-097-06, 27241-097-10, 27241-097-90, 27241-097-05, 27241-098-03, 27241-098-09, 27241-098-10, 27241-164-30, 27241-099-03, 27241-099-90, 27241-099-40
Code info: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 29, 2026
  2. Published
    May 13, 2026
Recall number
D-0514-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.