chlorproMAZINE Hydrochloride Tablets recall
FDA recall D-0159-2025 · initiated Dec 11, 2024
Glenmark Pharmaceuticals Inc., USA recalled chlorproMAZINE Hydrochloride Tablets in Dec 2024 — an FDA Class II recall (D-0159-2025) because CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended 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: 3,888
Details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Dec 11, 2024
- FDA report date
- Jan 1, 2025
Frequently asked
- Was chlorproMAZINE Hydrochloride Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled chlorproMAZINE Hydrochloride Tablets in Dec 2024 — an FDA Class II recall (D-0159-2025) because CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was chlorproMAZINE Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0159-2025 was: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- Is a recalled chlorproMAZINE Hydrochloride Tablets 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 chlorproMAZINE Hydrochloride Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025. 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-0159-2025.