Chlorpromazine Hydrochloride Tablets Recalled Due to Manufacturing Impurity
Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 25 mg tablets nationwide due to the presence of N-Nitroso Desmethyl Chlorpromazine above acceptable limits. No illnesses have been reported.
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: FDA Class II pharmaceutical recall with manufacturing deviation resulting in an impurity (N-Nitroso Desmethyl Chlorpromazine) above acceptable limits. No illnesses or hospitalizations reported, making this a risk-of-harm scenario without reported injury.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Chlorpromazine Hydrochloride Tablets, USP, 25 mg, supplied in 100-count bottles (NDC 16714-048-01). This is an FDA Class II recall.
The recall affects four specific production lots: Z305062 (expiration 31-08-25), Z306324 (expiration 30-11-25), Z401151 (expiration 28-02-26), and Z401152 (expiration 28-02-26). The tablets were found to contain N-Nitroso Desmethyl Chlorpromazine above the FDA's recommended acceptable intake limit due to a manufacturing deviation.
The affected product was distributed nationwide in the United States. Patients taking this medication should consult their healthcare provider regarding their concerns.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Pharmaceutical
- Hazard
- nitroso-impurity
- manufacturing-deviation
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 (7)
- Lot #: Z305062
- exp 31-08-25
- Z306324
- Exp Date 30-11-25
- Z401151
- Z401152
- Exp Date 28-02-26
Distribution
Distributed nationwide across the United States.
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