Class III U.S. Food and Drug Administration

Amneal Pharmaceuticals, LLC Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle recall: Cross Contamination with Other Products: due to a potential

Recall published 4 months ago

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0585-2026
Published
June 17, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Amneal Pharmaceuticals, LLC
Product type
Prescription & OTC drugs
Units affected
27,936 100-count bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot AM251676, EXP 11/31/2028

Products covered by this recall

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

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AM251676
  • EXP 11
  • 31
  • 2028 — 27
  • 936 100-count bottles

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 11
  • 31
  • 2028 — 27
  • 936 100-count bottles

NDC number

On the carton and again on the bottle or blister label.

  • 53746-544-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 50 mg
  • 100 count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Amneal Pharmaceuticals, LLC — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Amneal Pharmaceuticals, LLC — 400 Crossing Blvd Fl 3, Bridgewater, NJ, 08807-2863

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Amneal Pharmaceuticals, LLC prescription & otc drugs recalled?

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AM251676, EXP 11, 31; best-by date 11 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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