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Amneal Pharmaceuticals, LLC — Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
The Recall Registry rates this labelling issue — FDA Class III: unlikely to cause harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Amneal Pharmaceuticals, LLC
The product
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
Details
- Units affected
- 27,936 100-count bottles
- Recall date
- June 3, 2026
- Brand
- Amneal Pharmaceuticals, LLC
Nationwide within the USA
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Amneal Pharmaceuticals, LLC — 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, Br”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine