Doxepin Hydrochloride Capsules recall
FDA recall D-0566-2025 · initiated Jul 25, 2025
Alembic Pharmaceuticals Limited recalled Doxepin Hydrochloride Capsules in Jul 2025 — an FDA Class II recall (D-0566-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 9,492 bottles
Details
- Product
- 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
- Recalling company
- Alembic Pharms Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Jul 25, 2025
- FDA report date
- Aug 13, 2025
Frequently asked
- Was Doxepin Hydrochloride Capsules recalled?
- Alembic Pharmaceuticals Limited recalled Doxepin Hydrochloride Capsules in Jul 2025 — an FDA Class II recall (D-0566-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Doxepin Hydrochloride Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0566-2025 was: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Is a recalled Doxepin Hydrochloride Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Doxepin Hydrochloride Capsules are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot: 2305015142, Exp. Date: 9/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0566-2025.