Chlorpromazine Hydrochloride Tablets Recalled Due to Packaging Contamination
Amneal Pharmaceuticals is recalling specific lots of chlorpromazine hydrochloride 100-mg tablets nationwide due to a micro-organism detected in packaging material. No contamination was found on the tablets themselves.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The micro-organism was detected only in auxiliary packaging material, not on the tablets themselves, representing a theoretical rather than actual hazard.
Plain-English summary
Amneal Pharmaceuticals LLC is recalling specific lots of chlorpromazine hydrochloride tablets, 100 mg, in 100-count bottles, due to the detection of a micro-organism in auxiliary packaging material. The affected lots are AM240334, AM240335 (expiration 02/28/2027) and AM241031 (expiration 06/30/2027). No micro-organism was detected on the tablets themselves.
The recalled product was distributed nationwide in the United States. Approximately 14,923 bottles are affected by this recall.
Patients currently taking this medication should consult with their pharmacist or healthcare provider. Pharmacists and healthcare providers should quarantine remaining stock and report any adverse events to the FDA.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Antipsychotic
- Hazard
- microbial-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 (5)
- Lot: AM240334
- AM240335
- Exp Date 02/28/2027
- AM241031
- Exp Date 06/30/2027.
UPCs (2)
- 0369238105612
- 0369238106213
Distribution
Distributed nationwide across the United States.
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