Drug Recall: 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., B
Alembic Pharmaceuticals Limited · July 25, 2025
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Product Description
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
Distribution
Nationwide in the USA.
States Affected
NATIONWIDE
Quantity Affected
9,492 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0566-2025
Status: ongoing
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