CLASS III ONGOING Drug recall · Reported 27 May 2026 · FDA Enforcement Report
Primidone Tablets, USP, 250 mg ( unit dose blister) recalled
Amerisource Health Services is recalling Primidone Tablets, USP, 250 mg ( unit dose blister) per, distributed nationwide in the US. The recall was initiated on 1 May 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0536-2026
- FDA event ID
- 98884
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Brand
- Primidone
- Manufacturer
- American Health Packaging
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 1 May 2026
- FDA classified
- 18 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 1 May 2026 | Recall initiated by company | |
| 18 May 2026 | Classified by FDA | +17 days |
| 27 May 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Which lots are affected?
Lot#: 1027583, Exp 09/30/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98884This product is part of a recall event; the main page for the event is Primidone Tablets, USP, 50 mg ( unit dose blister) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
More recalls from Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 2 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Primidone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets USP, 250mg recalled by Lannett CompanyPrimidone | Lannett | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |