Chlorpromazine Hydrochloride Tablets recall
FDA recall D-0635-2025 · initiated Sep 3, 2025
Zydus Pharmaceuticals (USA) Inc recalled Chlorpromazine Hydrochloride Tablets in Sep 2025 — an FDA Class II recall (D-0635-2025) because CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake 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 above the recommended acceptable intake 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: N/A
Details
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Sep 3, 2025
- FDA report date
- Sep 17, 2025
Frequently asked
- Was Chlorpromazine Hydrochloride Tablets recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Chlorpromazine Hydrochloride Tablets in Sep 2025 — an FDA Class II recall (D-0635-2025) because CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake 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-0635-2025 was: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake 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 in the USA. The recall covers these lots — Lot #: Z306326, Exp Date 30-11-25; Z401155, Exp Date 28-02-26. 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-0635-2025.