Prescription Chlorpromazine Hydrochloride Tablets Recalled for Foreign Substance
AvKARE is recalling Chlorpromazine Hydrochloride Tablets, USP 50 mg due to the presence of a foreign substance. The recall affects 1512 cartons distributed nationwide.
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: This is an FDA Class II drug recall for contamination with a foreign substance. No illnesses or injuries have been reported. Per the rubric, contamination risks without reported harm are classified as High.
Plain-English summary
AvKARE is recalling Chlorpromazine Hydrochloride Tablets, USP 50 mg in 50-tablet unit dose cartons. The product is a prescription medication manufactured for AvKARE in Pulaski, Tennessee.
The recall was initiated due to the presence of a foreign substance in the product.
The affected product was distributed nationwide. The recalled lots are Lot #46824 (expiration 9/30/25) and Lot #47171 (expiration 12/31/25), totaling 1512 cartons.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- AvKARE
- Hazard
- foreign-substance
- contamination
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 # 46824
- Exp 9/30/25
- 47171
- Exp 12/31/25
Distribution
Distributed nationwide across the United States.
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