chlorproMAZINE Hydrochloride Tablets recall
FDA recall D-0361-2025 · initiated Apr 3, 2025
Zydus Pharmaceuticals (USA) Inc recalled chlorproMAZINE Hydrochloride Tablets in Apr 2025 — an FDA Class II recall (D-0361-2025) because CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended 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: 3144 bottles, pack size: 100's Count
Details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
- Initiated
- Apr 3, 2025
- FDA report date
- Apr 16, 2025
Frequently asked
- Was chlorproMAZINE Hydrochloride Tablets recalled?
- Zydus Pharmaceuticals (USA) Inc recalled chlorproMAZINE Hydrochloride Tablets in Apr 2025 — an FDA Class II recall (D-0361-2025) because CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim 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-0361-2025 was: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim 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: Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA. The recall covers these lots — Lot #: Z400069, Exp.: 12/31/2025. 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-0361-2025.