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Drug FDA Class II Ongoing cGMP deviation

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

Asclemed USA Inc. Published Jun 10, 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 Asclemed USA Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Hazards

N-nitroso-duloxetine · primary

Affected products (1)

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

DULOXETINE · 50 bottles

NDC: 76420-623, 76420-633, 76420-634, 76420-636, 76420-633-20, 76420-633-30, 76420-633-60, 76420-633-90, 76420-633-01, 76420-633-05, 76420-633-00, 76420-634-20, 76420-634-30, 76420-634-60, 76420-634-90, 76420-634-01, 76420-634-00, 76420-636-20, 76420-636-30, 76420-636-60, 76420-636-90, 76420-636-01, 76420-623-20, 76420-623-30, 76420-623-60, 76420-623-90, 76420-623-01, 76420-623-00
Lot codes: 050725G-30
Code info: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    May 14, 2026
  2. Published
    Jun 10, 2026
Recall number
D-0555-2026
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.