AvKare chlorpromazine 100 mg cartons recalled over presence of foreign substance
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in 50-tablet unit dose cartons for AvKare, are recalled nationwide for the presence of a foreign substance. 2,003 cartons are affected.
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 foreign substance in a prescription medicine is a potential harm and no injuries are reported.
Plain-English summary
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in 50-tablet (5x10) unit dose cartons and available on prescription only, manufactured for AvKare of Pulaski, Tennessee, NDC 50268-165-15, are being recalled. Affected lots are 47089 expiring 12/31/25 and 47604 expiring 03/31/26. The recall covers 2,003 cartons distributed nationwide.
The recall was issued for the presence of a foreign substance. The FDA classified the action as Class II. The notice does not describe the substance further.
Patients should check the lot number on their carton against the recall and should speak to their pharmacist about a replacement supply before stopping a prescribed medicine.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- AvKARE
- Category
- Drug — Central Nervous System
- Hazard
- foreign-substance
- prescription-drug
- class-ii
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 # 47089
- Exp 12/31/25
- 47604
- Exp 03/31/26
Distribution
Distributed nationwide across the United States.
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