Lannett Primidone Tablets Recall: Cross Contamination Risk
Lannett recalls Primidone 250mg tablets due to trace acemetacin contamination. Affected lots have specific expiration dates and are prescription-only.
Lower-risk recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Contact the company
What happened, in plain English
Lannett is recalling Primidone 250mg tablets that may contain trace amounts of acemetacin from cross contamination. This could affect people taking the medication as it might cause unintended side effects. Read more at govinfonow.com/recall/31335-lannett-primidone-tablets-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31335-lannett-primidone-tablets-recall-cross-contamination-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0533-2026
Cite this page
“Lannett Primidone Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31335-lannett-primidone-tablets-recall-cross-contamination-risk. Based on FDA recall #D-0533-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0533-2026%22&limit=1).
Why it’s dangerous
The tablets were cross-contaminated with acemetacin during manufacturing, which could lead to unintended side effects for people taking the medication. This is a trace contamination issue, not a significant risk.
Who’s affected
Prescription patients using the recalled Primidone tablets. Those with specific lot numbers and expiration dates are most at risk.
How to tell if you have this one
Check for lot numbers: 25283038A (exp 1/31/2028), 25283564A/25283565A (exp 3/31/2028), 25285712A (exp 8/31/2028), 25284105A (exp 4/30/2028), 25284874A/25284875A (exp 8/31/2028). The product is prescription-only.
- Brand
Lannett- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot number on the bottle label to determine if it's affected.
Contact Your Doctor
Talk to your healthcare provider about whether you should stop using the medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
Check the lot number on the bottle. If it matches the affected lots listed, contact your doctor to discuss next steps.
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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-0533-2026 (April 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0533-2026 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.