Class II U.S. Food and Drug Administration

Mylan Pharmaceuticals Inc Acamprosate Calcium, Delayed-Release Tablets, 333 mg recall: Failed Dissolution Specifications

Recall published 2 months ago

Failed Dissolution Specifications

The hazard: Potency, impurity or stability failure

The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

What the notice says: Failed Dissolution Specifications

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0774-2026
Published
August 26, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Mylan Pharmaceuticals Inc
Product type
Prescription & OTC drugs
Distribution
Nationwide
Made in
United States
Lot / code info
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80

Products covered by this recall

Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.

Check your product

The notice names 5 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.

  • 3227809

Best-by / use-by date

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

  • 10
  • 2026

NDC number

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

  • 0378-6333-80

Package size

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

  • 333 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 Potency

Mylan Pharmaceuticals Inc — The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  3. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  4. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.

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: Mylan Pharmaceuticals Inc — 3711 Collins Ferry Rd, Morgantown, WV, 26505-2362

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 Mylan Pharmaceuticals Inc prescription & otc drugs recalled?

Failed Dissolution Specifications Failed Dissolution Specifications

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 3227809; best-by date 10 or 2026. 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 before you do anything else.

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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