HIGH

Chlorpromazine Hydrochloride 25 mg Tablets Recalled Nationwide Over Foreign Substance in Packaging

A recall of chlorpromazine hydrochloride tablets is active nationwide in the United States. A specific lot of packaging material to coils used in manufacturing contained a foreign substance with a microorganism detected. Tablets themselves tested negative for microorganisms. Consumers and healthcare providers should stop using the product immediately and contact Amerisource Health Services LLC or

Quick Facts at a Glance

Recall Date
August 27, 2025
Hazard Level
HIGH
Brands
CHLORPROMAZINE HYDROCHLORIDE, American Health Packaging
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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 Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter

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About This Product

Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric conditions. It is distributed in blisterpackaged tablets.

Why This Is Dangerous

A foreign substance in packaging material was detected, with a microorganism present on the packaging coil. No tablets were found contaminated.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may need to stop taking the affected lot and work with healthcare providers to obtain a safe replacement, potential disruption to treatment timelines.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 60687-430-65 (50 blisterpack) or 60687-430-01 (100 blisterpack)
  2. Check individual NDC 60687-430-11
  3. Inspect for Lot numbers starting with 1020xxx and Exp dates 2026
  4. Verify packaging coil material if visible on packaging

Where to find product info

Recall notices and FDA enforcement page D-0647-2025

What timeline to expect

Refunds/replacements via a letter notification; process timelines vary by distributor

If the manufacturer is unresponsive

  • Escalate to consumer protection agencies
  • File a formal complaint with the FDA
  • Maintain records of all correspondence

How to prevent similar issues

  • Check future drug packaging for foreign-material warnings
  • Verify supplier quality controls
  • Confirm lot and expiry dates before use
  • Keep documentation for refunds

Documentation advice

Keep all recall notices, packaging, lot numbers, and correspondence for records

Product Details

Brand: CHLORPROMAZINE HYDROCHLORIDE. Distributor: American Health Packaging, Columbus, Ohio 43217. Packaging options: a) 50 blisterpacks (5x10) NDC 60687-430-65; Individual Dose NDC 60687-430-11; b) 100 blisterpacks (10x10) NDC 60687-430-01; Individual Dose NDC 60687-430-11. Quantity recalled: 2,708 cartons. Class II recall. Distribution: Nationwide in the USA. Recall date: 2025-08-27.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 2,708 cartons recalled
  • Lot: a) 1020919, 1021133, 1021447, 1021741, 1022202, 1022474; Exp 09/30/2026 to 12/31/2026
  • Lot: b) 1020460, 1022417; Exp 08/31/2026 to 12/31/2026
  • Packaging material: auxiliary polyester coil with detected microorganism
  • Hazard level: HIGH
  • Status: ACTIVE

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
POISONINGOTHER

Product Details

Model Numbers
Lot: a)1020919
1021133
Exp 09/30/2026
1021447
Exp 10/31/2026
+9 more
UPC Codes
60687-419
60687-430
60687-441
+12 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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