HIGH

Amneal Pharmaceuticals Recalls Chlorpromazine Tablets Over Contamination Risk

Amneal Pharmaceuticals recalled 13,130 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025, due to contamination concerns. The recall affects specific lots identified by their lot numbers AM240147, AM240148, AM240664, and AM240665. Consumers should stop using the tablets immediately and contact their healthcare provider for further guidance.

Hazard Information

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter

Product Details

The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 100-count bottles. The affected lots are AM240147, AM240148, AM240664, and AM240665, with expiration dates of January 31, 2027, and April 30, 2027. The product was distributed nationwide in the USA.

The Hazard

The recall was initiated due to the presence of a foreign substance, specifically a micro-organism found on auxiliary polyester coil used in packaging. No micro-organisms were detected on the tablets themselves. This contamination poses a high risk to consumers.

Reported Incidents

There have been no reported injuries or illnesses associated with this recall. However, the potential risk from contaminated packaging warrants immediate action.

What to Do

Stop using the recalled tablets immediately. Consumers should contact Amneal Pharmaceuticals, LLC or their healthcare provider for guidance regarding the recall.

Contact Information

For more information, consumers can visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0617-2025. Amneal Pharmaceuticals can also be contacted directly for further assistance.

Key Facts

  • Recall date: August 18, 2025
  • Quantity recalled: 13,130 bottles
  • Expirations: 01/31/2027, 04/30/2027
  • No micro-organism detected on tablets
  • Contact healthcare provider for guidance
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot: AM240147
AM240148
Lot AM240664
AM240665
UPC Codes
69238-1054
69238-1056
69238-1058
+7 more
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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