Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Doxepin Hydrochloride Capsules Recalled by Alembic Pharmaceuticals Limited Due to CGMP Deviations: Presence of Nitrosamine Drug Substance Related...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alembic Pharmaceuticals Limited directly.
Affected Products
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
Quantity: 9,492 bottles
Why Was This Recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report