Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only
Recalled by Amneal Pharmaceuticals, LLC
Class III — least serious
Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Amneal Pharmaceuticals, LLC has recalled Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 17, 2026 and was initiated on June 3, 2026. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, with approximately 27,936 100-count bottles affected. The company behind the recall is Amneal Pharmaceuticals, LLC, based in Bridgewater, NJ. The FDA describes the product as: “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”
Why was Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only recalled?
According to the FDA, the stated reason for the recall is: “Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.”
What should you do?
If you think you may have bought Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, compare it against the product description and identifying codes (Lot AM251676, EXP 11/31/2028) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Amneal Pharmaceuticals, LLC or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- June 17, 2026
- Recall started
- June 3, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only recalled?+
According to the FDA: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac…
How serious is this recall?+
Class III — least serious. Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
What should I do if I have Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0585-2026. Information last synced from the FDA on July 5, 2026.