Class III U.S. Food and Drug Administration

Amerisource Health Services LLC Primidone Tablets, USP, 50 mg, 100 Tablets per carton recall: Cross contamination with other products: API contaminated with trace amounts

Recall published 5 months ago

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

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: API contaminated with trace amounts of Acemetacin API.

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-0537-2026
Published
May 27, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Amerisource Health Services LLC
Product type
Prescription & OTC drugs
Units affected
225,000 tablets
Distribution
Nationwide
Made in
United States
Lot / code info
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027

Products covered by this recall

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

Check your product

The notice names 19 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.

  • 1028739
  • exp 12
  • 31
  • 2027
  • 1025622
  • exp 06
  • 30
  • 2027 — 225
  • 000 tablets

Best-by / use-by date

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

  • 12
  • 31
  • 2027
  • 06
  • 30
  • 2027 — 225
  • 000 tablets

NDC number

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

  • 68084-202-01
  • 68084-202-11

Package size

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

  • 50 mg

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

Amerisource Health Services 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. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

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: Amerisource Health Services LLC — 2550 John Glenn Ave Ste A, Columbus, OH, 43217-1188

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 Amerisource Health Services LLC prescription & otc drugs recalled?

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 1028739, exp 12, 31; best-by date 12 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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