Chlorpromazine 10 mg tablets recalled over N-nitroso impurity above limit
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a nitrosamine above the recommended acceptable intake limit is a potential harm and no injuries are reported.
Plain-English summary
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, in 100-count bottles and available on prescription only, manufactured by Zydus Lifesciences Ltd. in Baddi, India for Northstar Rx LLC of Memphis, Tennessee, NDC 16714-047-01, are being recalled. Affected lots are Z403011 expiring 30-04-26 and Z407335 expiring 30-11-26. Distribution was nationwide.
The recall follows current good manufacturing practice deviations: the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Central Nervous System
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: Z403011
- Exp Date 30-04-26
- Z407335
- Exp Date 30-11-26
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same brand · CHLORPROMAZINE HYDROCHLORIDE
- ModerateChlorpromazine 100 mg cartons recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- ModeratePackaged chlorpromazine cartons recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- ModerateChlorpromazine 25 mg blisterpacks recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- ModerateChlorpromazine 50 mg blisterpacks recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- HighChlorpromazine 200 mg from Zydus recalled over N-nitroso desmethyl impurity
FDA (Drugs) · 2025-09-17
Same manufacturer · Zydus Pharmaceuticals (USA) Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · nitrosamine impurity
See all →- HighEnovachem duloxetine capsules exceed the nitrosamine acceptable intake limit
FDA (Drugs) · 2026-06-10
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08