Carbamazepine 200mg Tablets Recall: Failed Dissolution Specifications
The Harvard Drug Group recalls Carbamazepine 200mg tablets due to failed dissolution specifications. This may affect medication effectiveness. Check your product details to see if you are affected.
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Failed Dissolution Specifications
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What happened, in plain English
The Harvard Drug Group is recalling Carbamazepine 200mg tablets that failed dissolution specifications. This could mean the medication doesn't work properly, so affected users should contact their doctor. Read more at govinfonow.com/recall/35986-carbamazepine-200mg-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/35986-carbamazepine-200mg-tablets-recall-failed-dissolution-specifications · Updated August 18, 2026 · FDA enforcement record: FDA #D-0807-2021
Cite this page
“Carbamazepine 200mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35986-carbamazepine-200mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0807-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0807-2021%22&limit=1).
Why it’s dangerous
The tablets failed to dissolve properly as required by the manufacturer. This could lead to inconsistent medication levels in the body, potentially reducing effectiveness. However, the recall does not mention serious injury risks.
Who’s affected
People who have the recalled Carbamazepine 200mg tablets (NDC 0904-6172-61, Lot R01562) prescribed by a doctor. Those with seizure conditions are most at risk if the medication isn't effective.
How to tell if you have this one
Check for the NDC code 0904-6172-61 and lot number R01562 on the carton. The product is a prescription-only 100-count unit dose carton of Carbamazepine 200mg tablets.
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0904-6172-61 and lot number R01562 on the carton.
Where it went and when
Where it was distributed
Distributed in North Carolina.
FDA distribution: “NC” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: North Carolina.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0807-2021 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0807-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.