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Drug FDA Class II Ongoing cGMP deviation

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

Alembic Pharmaceuticals Limited Published Aug 13, 2025

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 Alembic Pharmaceuticals Limited 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 above the proposed interim limit.

Hazards

N-nitroso-doxepin · primary

Affected products (1)

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

DOXEPIN HYDROCHLORIDE · 9,492 bottles

NDC: 62332-637, 62332-638, 62332-645, 62332-639, 62332-640, 62332-637-31, 62332-637-91, 62332-638-31, 62332-638-91, 62332-645-31, 62332-645-91, 62332-639-31, 62332-639-91, 62332-640-31, 62332-640-91, 2305015142
Lot codes: 2305015142
Code info: Lot: 2305015142, Exp. Date: 9/30/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 25, 2025
  2. Published
    Aug 13, 2025
Recall number
D-0566-2025
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.