Chlorpromazine 25 mg fifty count packs recalled over nitrosamine impurity
Major Pharmaceuticals is recalling 2,064 fifty-tablet blister packs of Chlorpromazine Hydrochloride Tablets USP 25 mg because a nitrosamine impurity exceeded the recommended 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: Scored 3 under the risk-of-harm criterion: a named nitrosamine impurity exceeding its recommended intake limit is a defined safety threshold breach, with no injuries reported.
Plain-English summary
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, in 50-tablet (5x10) blister packages, packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana, are being recalled for CGMP deviations: the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit.
The recall covers 2,064 blister packs carrying NDC 0904-7130-06, from lots N01943 and N02025, expiring 28 February 2026. The product was distributed nationwide. The FDA has classified the recall as Class II.
The enforcement record identifies the nitrosamine impurity and the exceeded intake limit, and reports no injuries.
Chlorpromazine is a prescription medicine, so patients holding the affected lots should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
- Category
- Drug — Antipsychotic
- Affected units
- 2,064
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 (2)
- Lots N01943 and Lot N02025
- exp. date 02/28/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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.
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