Carbamazepine 400mg Tablets Recall: Failed Dissolution Specifications
Amerisource Health Services recalls 400mg carbamazepine extended-release tablets due to failed dissolution specifications. Affected lots may not release medication properly.
Lower-risk recall
Failed Dissolution Specifications.
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What happened, in plain English
Amerisource Health Services is recalling carbamazepine extended-release tablets that failed dissolution tests. This means the medication may not work as intended, potentially causing treatment failure. Read more at govinfonow.com/recall/31784-carbamazepine-400mg-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/31784-carbamazepine-400mg-tablets-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0675-2025
Cite this page
“Carbamazepine 400mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31784-carbamazepine-400mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0675-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0675-2025%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not release medication properly in the body. This could lead to ineffective treatment for conditions like seizures. The risk is not immediate harm but potential treatment failure.
Who’s affected
Prescription patients who received the recalled lot (1024078) of carbamazepine 400mg tablets. Patients on seizure medication are most at risk of treatment failure.
How to tell if you have this one
Check for carton NDC 60687-594-21 or individual dose NDC 60687-594-11. The lot number 1024078 with expiration date 08/31/2026 is affected.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the carton to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0675-2025 (September 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0675-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.