Quick Facts at a Glance
- Recall Date
- September 15, 2025
- Hazard Level
- HIGH
- Brands
- Carbamazepine, American Health Packaging
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Carbamazepine, American Health Packaging
- Product type
- Carbamazepine Extended-Release Tablets 400 mg
- Model numbers
- Lot #: 1024078, Exp. Date 08/31/2026
- UPC codes
- 60687-583, 60687-594, 60687-583-11, 60687-583-21, 60687-594-11, 60687-594-21
- Sizes
- 400 mg
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 15, 2025
Reported by FDA DRUG
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Dissolution Specifications.
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
About This Product
Carbamazepine extended-release tablets are used to treat seizures and nerve pain. This recall involves 360 cartons distributed nationwide.
Why This Is Dangerous
Failure to dissolve as specified can alter drug release and absorption, potentially impacting effectiveness and safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may affect adherence to prescribed therapy and require medical guidance for safe continuation.
Practical Guidance
How to identify if yours is affected
- Check carton NDC 60687-594-21
- Check Individual Dose NDC 60687-594-11
- Inspect Lot #1024078 and Exp. Date 08/31/2026
- Confirm 30 tablets per carton (3x10 cards)
- Confirm 360 cartons distributed nationwide
Where to find product info
On the carton and patient information leaflets; FDA enforcement page for D-0675-2025
What timeline to expect
Refund or replacement timelines will be provided in recall communications by Amerisource Health Services LLC and pharmacies
If the manufacturer is unresponsive
- Document all communications
- File a consumer complaint with the FDA recall search
- Consult pharmacist for alternatives
How to prevent similar issues
- Verify NDC and lot numbers before dispensing new prescriptions
- Ask pharmacists about dissolution specifications and stability
- Use approved pharmacies and verify shelf life at receipt
Documentation advice
Keep the recall notice, receipts, and any correspondence with healthcare providers or pharmacies
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Product Details
Carbamazepine Extended-Release Tablets, USP 400 mg. 30 tablets per carton (3x10 unit dose cards). Rx Only. Distributor: American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; Individual Dose NDC 60687-594-11. Quantity: 360 cartons. Lot #: 1024078. Exp. Date: 08/31/2026. Sold nationwide in the USA. Generic name CARBAMAZEPINE; Brand CARBAMAZEPINE.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Individual Dose NDC 60687-594-11
- High-risk drug category (Rx only)
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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