Alembic Pharmaceuticals recalls 10mg Doxepin capsules due to nitrosamine impurity exceeding safety limits. This prescription drug may pose health risks if consumed. Consumers should contact the manufacturer for details.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Alembic Pharmaceuticals is recalling 10mg Doxepin Hydrochloride capsules because they contain a harmful nitrosamine impurity above safety limits. This could pose health risks if taken as prescribed.
Nitrosamines are known carcinogens that can cause cancer when ingested in high amounts. The presence of this impurity above the safety limit in the capsules may lead to health risks with long-term use.
Prescription drug users who have the specific 100-count Doxepin capsules with NDC 62332-637-31 and lot number 2305015142 are affected. Patients taking this medication for depression or anxiety may be at risk.
Check for the product name 'Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules' with NDC code 62332-637-31 and lot number 2305015142. These were manufactured in India and distributed in the US by Alembic Pharmaceuticals.
Look for the NDC code 62332-637-31 and lot number 2305015142 on the packaging.
The recall states the presence of a nitrosamine impurity above safety limits, which may pose health risks. Do not take these capsules until the manufacturer provides further instructions.
The recall record does not specify a remedy or replacement process. Contact Alembic Pharmaceuticals for assistance.
The expiration date for the recalled capsules is September 30, 2025.
We’ve drafted a message you can send Alembic to request your refund or repair — edit it as you like.
Subject: Recall D-0566-2025 — Alembic Alembic Hello, I own a Alembic that is covered by recall D-0566-2025 from Alembic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
