Harvard Drug Group Entacapone Tablets 200mg Recall: Failed Dissolution Specifications
Harvard Drug Group recalls 200mg Entacapone Tablets due to failed dissolution specifications. Affected units have specific NDC and lot numbers. Consumers should contact the manufacturer for details.
Lower-risk recall
Failed Dissolution Specifications
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What happened, in plain English
Harvard Drug Group is recalling 200mg Entacapone Tablets that failed dissolution specifications. This means the medication may not work as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/36014-harvard-drug-group-entacapone-tablets-200mg-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/36014-harvard-drug-group-entacapone-tablets-200mg-recall-failed-dissolution-specifications · Updated September 23, 2026 · FDA enforcement record: FDA #D-0806-2021
Cite this page
“Harvard Drug Group Entacapone Tablets 200mg Recall: Failed Dissolution Specifications.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/36014-harvard-drug-group-entacapone-tablets-200mg-recall-failed-dissolution-specifications. Based on FDA recall #D-0806-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0806-2021%22&limit=1).
Why it’s dangerous
The tablets failed to dissolve properly as required by the drug's specifications. This could lead to inconsistent medication levels in the bloodstream, potentially reducing effectiveness.
Who’s affected
People prescribed Entacapone Tablets by a doctor who received the recalled units. Those with specific NDC and lot numbers are most at risk.
How to tell if you have this one
Check for NDC code 0904-6822-04 and lot numbers N00187 (05/2022), N00245 (06/2022), N00273 (07/2022), or N00355 (11/2022).
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC code and lot numbers listed in the recall notice to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “CO, FL, MO, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Florida, Missouri, Ohio.
Recall timeline
FDA terminated this recall 19 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-0806-2021 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0806-2021 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.