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
Drug Recall
Official source record
- Recall number
- D-0585-2026
- Event ID
- 99146
- Classification
- Class III
- Status
- Ongoing
- Recalling company
- Amneal Pharmaceuticals, LLC
- 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.
- Report date
- June 17, 2026
- Recall initiation date
- June 3, 2026
- Termination date
- Not terminated as of this source record
- Distribution pattern
- Nationwide within the USA.
Drug product identifiers
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Brand name
- PRIMIDONE
- Generic name
- PRIMIDONE
- Substance name
- PRIMIDONE
- Product NDCs
- 53746-544; 53746-545
- Package NDCs
- 53746-544-01; 53746-544-05; 53746-544-10; 53746-545-01; 53746-545-05; 53746-545-10
- Route
- ORAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
