Amneal Recalls Primidone Tablets Due to Cross-Contamination Risk
Amneal Pharmaceuticals recalls 27,936 bottles of Primidone 50mg tablets due to potential cross-contamination with Acemetacin API. Check your lot number.
Use caution until it’s fixed
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Contact the company
What happened, in plain English
Amneal Pharmaceuticals is recalling 27,936 bottles of Primidone Tablets, USP, 50 mg because they may be contaminated with another drug ingredient called Acemetacin API. This issue stems from a problem at the API manufacturer where the raw materials were produced. The recall affects bottles distributed nationwide in the USA. Read more at govinfonow.com/recall/31228-amneal-recalls-primidone-tablets-due-to-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31228-amneal-recalls-primidone-tablets-due-to-cross-contamination-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0585-2026
Cite this page
“Amneal Recalls Primidone Tablets Due to Cross-Contamination Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31228-amneal-recalls-primidone-tablets-due-to-cross-contamination-risk. Based on FDA recall #D-0585-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0585-2026%22&limit=1).
Why it’s dangerous
The tablets may contain Acemetacin API due to cross-contamination during manufacturing. This unintended presence of another drug's active ingredient could lead to unexpected side effects or interactions for patients who are not taking Acemetacin.
Who’s affected
Patients who have been prescribed Primidone Tablets, USP, 50 mg by Amneal Pharmaceuticals and purchased them anywhere in the United States are affected. Individuals taking this specific medication from the identified lot numbers are at risk of exposure to the contaminant.
How to tell if you have this one
Look for Primidone Tablets, USP, 50 mg in 100-count bottles. Check the label for NDC 53746-544-01 and Lot number AM251676 with an expiration date of 11/31/2028. The bottle should indicate it was manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ.
- Brand
Amneal Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Primidone tablets match the recalled NDC 53746-544-01 and Lot AM251676.
Contact Your Pharmacist
Speak with your pharmacy or healthcare provider to determine if you have the recalled product and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within 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 14 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.
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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-0585-2026 (June 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0585-2026 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.