The Recall Desk
ModerateFDA (Drugs)·D-0649-2025·Announced 2025-09-24

Chlorpromazine 100 mg cartons recalled over micro-organism on packaging coil

Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in blisterpack cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,757 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, 100 mg, in 100-tablet (10x10) blisterpacks per carton and available on prescription only, distributed by American Health Packaging of Columbus, Ohio, carton NDC 60687-452-01 with individual unit dose blister pack NDC 60687-452-11, are being recalled. Affected lots are 1021652 expiring 10/31/2026, 1022539 expiring 01/31/2027 and 1023666 expiring 03/31/2027. The recall covers 1,757 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
1,757

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: 1021652
  • Exp 10/31/2026
  • 1022539
  • Exp 01/31/2027
  • 1023666
  • Exp 03/31/2027

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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