Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brands
- Chlorpromazine Hydrochloride, Amneal Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Chlorpromazine Hydrochloride, Amneal Pharmaceuticals
- Product type
- Chlorpromazine Hydrochloride Tablets 25 mg, 100-count bottles (Rx Only)
- Model numbers
- AM240617, AM240618
- UPC codes
- 69238-1054, 69238-1056, 69238-1058, 69238-1060, 69238-1062, 69238-1054-1, 69238-1056-1, 69238-1058-1 +2 more
- Sizes
- 100-count bottles
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 18, 2025
Reported by FDA DRUG
September 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric conditions. It is sold as prescription-only medication.
Why This Is Dangerous
A manufacturing packaging coil contained a microorganism. The tablets themselves were not contaminated, but the packaging defect raises contamination risk.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Patients with affected lots should stop using the product and await guidance. The recall covers 7,228 bottles distributed nationwide in the U.S.
Practical Guidance
How to identify if yours is affected
- Verify NDC 69238-1056-1 on the bottle.
- Check Lot AM240617 or AM240618.
- Verify Expiration Date 04/30/2027.
Where to find product info
NDC 69238-1056-1; Lot AM240617; Lot AM240618; Exp 04/30/2027; Manufactured in India; Distributed by Amneal Pharmaceuticals LLC, NJ.
What timeline to expect
Refunds/replacements expected in 4-6 weeks after eligibility is confirmed.
If the manufacturer is unresponsive
- Document all communications with Amneal.
- If Amneal is unresponsive, contact the FDA or your pharmacist for guidance.
How to prevent similar issues
- Only obtain prescription medications from licensed pharmacies.
- Monitor recall updates from Amneal and FDA.
- Discuss alternatives with your healthcare provider if needed.
Documentation advice
Keep recall letter, bottle labels, lot numbers, and any correspondence with Amneal for records.
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Product Details
NDC 69238-1056-1. Lot AM240617 and Lot AM240618. Expiration date 04/30/2027. Quantity recalled: 7,228 bottles of 100-count each. Manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Sold nationwide in the U.S. Rx Only. Category: Health & Personal Care; Drugs & Medications.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot AM240617 and Lot AM240618 affected
- Packaging coil contamination detected
- Tablets not contaminated
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Safety Guide
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