How serious is this recall?

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What should someone who has this product do?

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (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) and recall number D-0585-2026, then.

Has Amneal Pharmaceuticals, LLC had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Amneal Pharmaceuticals, LLC so far. Argus ingests new FDA enforcement records daily.

FDA Class III Recall: PRIMIDONE by Amneal Pharmaceuticals, LLC

Key facts

Recalling firm	Amneal Pharmaceuticals, LLC
Manufacturer	Amneal Pharmaceuticals of New York LLC
Brand name	PRIMIDONE
Product description	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
Classification	Class III
Recall number	D-0585-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
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.

Key takeaway: Amneal Pharmaceuticals, LLC recalled 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 on 2026-06-17. FDA classified this action as a Class III recall (recall number D-0585-2026). 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.. Recall status: Ongoing. This is a drug-category FDA recall record.

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is Amneal Pharmaceuticals, LLC and the affected product is described in FDA's record 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. FDA's 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.. The recall is tracked under FDA recall number D-0585-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with 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 -- and the recall number D-0585-2026. If it matches, stop using or distributing it and contact Amneal Pharmaceuticals, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Amneal Pharmaceuticals, LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Amneal Pharmaceuticals, LLC: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?: FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What should someone who has this product do?: Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (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) and recall number D-0585-2026, then.
Has Amneal Pharmaceuticals, LLC had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for Amneal Pharmaceuticals, LLC so far. Argus ingests new FDA enforcement records daily.
What is the FDA recall number for this event?: FDA recall number D-0585-2026.

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Full FDA history for Amneal Pharmaceuticals, LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class III Recall: PRIMIDONE by Amneal Pharmaceuticals, LLC. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-amneal-pharmaceuticals-llc-d-0585-2026

MLA

"FDA Class III Recall: PRIMIDONE by Amneal Pharmaceuticals, LLC." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-amneal-pharmaceuticals-llc-d-0585-2026.

Chicago

Argus HQ Research. "FDA Class III Recall: PRIMIDONE by Amneal Pharmaceuticals, LLC." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-amneal-pharmaceuticals-llc-d-0585-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_amneal_pharmaceuticals_llc_d_0585_2026_2026,
  title = {FDA Class III Recall: PRIMIDONE by Amneal Pharmaceuticals, LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/fda-recall-amneal-pharmaceuticals-llc-d-0585-2026},
  note = {Accessed: August 29, 2026}
}

Source: FDA.gov — Recalls ↗