The Recall Desk
ModerateFDA (Drugs)·D-0648-2025·Announced 2025-09-24

Chlorpromazine 50 mg blisterpacks recalled over micro-organism on packaging coil

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,062 cartons are affected.

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: Rubric level 2 covers precautionary recalls; the contamination was found on a packaging component and the notice states no micro-organism was detected on any tablets.

Plain-English summary

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 100-tablet (10x10) blisterpacks and available on prescription only, distributed by American Health Packaging of Columbus, Ohio, NDC 60687-441-01 with individual dose NDC 60687-441-11, are being recalled. Affected lots are 1022159 expiring 12/31/2026, 1023299 expiring 03/31/2027 and 1024057 expiring 04/30/2027. The recall covers 1,062 cartons distributed nationwide.

The recall was issued for the presence of a foreign substance: a specific lot of auxiliary polyester coil used in product packaging at the manufacturing site was found to contain a micro-organism. The notice states that no micro-organism was detected on any tablets. The FDA classified the action as Class II.

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
Amerisource Health Services LLC
Category
Drug — Central Nervous System
Hazard
Affected units
1,062

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 (6)

  • Lot: 1022159
  • exp 12/31/2026
  • 1023299
  • exp 03/31/2027
  • 1024057
  • Exp 04/30/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Amerisource Health Services LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same brand · CHLORPROMAZINE HYDROCHLORIDE

Same manufacturer · Amerisource Health Services LLC

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Same hazard · packaging contamination

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