Amerisource Health Primidone Tablets Recall: Cross Contamination Risk
Amerisource Health Services recalls Primidone 50mg tablets due to cross contamination with Acemetacin. Affected lots may pose health risks if taken.
Lower-risk recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Contact the company
What happened, in plain English
Amerisource Health Services is recalling Primidone 50mg tablets that may contain trace amounts of Acemetacin from cross contamination. This could cause health issues if taken by people who need the medication. Read more at govinfonow.com/recall/31318-amerisource-health-primidone-tablets-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31318-amerisource-health-primidone-tablets-recall-cross-contamination-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0537-2026
Cite this page
“Amerisource Health Primidone Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31318-amerisource-health-primidone-tablets-recall-cross-contamination-risk. Based on FDA recall #D-0537-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0537-2026%22&limit=1).
Why it’s dangerous
The tablets may have been contaminated with trace amounts of Acemetacin during manufacturing. This cross contamination could lead to unintended medication effects if taken by patients.
Who’s affected
People with prescriptions for Primidone 50mg tablets who received these specific lots are affected. Those with medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check your carton for NDC 68084-202-01 or individual dose NDC 68084-202-11. Look for lot numbers 1028739 (expiring 12/31/2027) or 1025622 (expiring 06/30/2027).
- Brand
Amerisource Health Services- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Ongoing- Distribution
USA Nationwide- NDC
68084-203-11, 68084-203-01, 68084-202-11, 68084-202-01
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0536-2026 | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11; Lot#: 1027583, Exp 09/30/2027 | 63,500 tablets |
| D-0537-2026 | Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11; Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 | 225,000 tablets |
What to do — step by step
Check Your Medication
Verify your carton has NDC 68084-202-01 or individual dose NDC 68084-202-11 with the specified lot numbers.
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 26 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-0537-2026 (May 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0537-2026 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.