CLASS III ONGOING Drug recall · Reported 17 Jun 2026 · FDA Enforcement Report
Primidone Tablets, USP, 50 mg recalled by Amneal Pharmaceuticals
Amneal Pharmaceuticals is recalling Primidone Tablets, USP, 50 mg per, distributed nationwide in the US. The recall was initiated on 3 Jun 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-0585-2026
- FDA event ID
- 99146
- Recalling firm
- Amneal Pharmaceuticals, Bridgewater, NJ
- Brand
- Primidone
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 3 Jun 2026
- FDA classified
- 10 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 3 Jun 2026 | Recall initiated by company | |
| 10 Jun 2026 | Classified by FDA | +7 days |
| 17 Jun 2026 | Published in enforcement report | +7 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: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Product as listed by the FDA
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Where it was distributed
Nationwide within the USA.
Questions about this recall
Why was it recalled?
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Which lots are affected?
Lot AM251676, EXP 11/31/2028
Where was it sold?
Nationwide within the USA.
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.
More recalls from Amneal Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalledEstradiol | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
Other Primidone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets USP, 250mg recalled by Lannett CompanyPrimidone | Lannett | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | 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 |