HIGH

Amneal Pharmaceuticals Recalls Chlorpromazine Hydrochloride Tablets

Amneal Pharmaceuticals recalled 3,363 bottles of Chlorpromazine Hydrochloride Tablets on August 18, 2025. The recall stems from the presence of a microorganism in packaging material. No microorganisms were detected in the tablets themselves, but consumers should stop using the product immediately.

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, 200 mg, in 100-count bottles. The lot numbers affected are AM240336 and AM240337, with an expiration date of February 28, 2027. The product was distributed nationwide.

The Hazard

The recall is due to the presence of a foreign substance detected in auxiliary polyester coil used in packaging. Although no microorganisms were found in the tablets, the risk of contamination remains.

Reported Incidents

No incidents or injuries have been reported related to the contaminated packaging. The recall was initiated proactively to ensure consumer safety.

What to Do

Stop using the recalled product immediately. Contact Amneal Pharmaceuticals, LLC or consult your healthcare provider for further guidance.

Contact Information

For more information, visit the FDA website or contact Amneal Pharmaceuticals at their customer service number.

Key Facts

  • Recalled product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg
  • Recall date: August 18, 2025
  • Quantity recalled: 3,363 bottles
  • No reported injuries or incidents
  • Stop use immediately and contact your healthcare provider
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Safety Assessment

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

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot: AM240336
AM240337
Exp Date 02/28/2027
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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