Class II U.S. Food and Drug Administration

Amneal Pharmaceuticals, LLC traMADol Hydrochloride Tablets, USP, 50 mg recall: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol

Recall published 7 months ago

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

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 Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

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-0408-2026
Published
April 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Amneal Pharmaceuticals, LLC
Product type
Prescription & OTC drugs
Units affected
29,542 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.

Products covered by this recall

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.

Check your product

The notice names 10 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.

  • AM230987
  • 2026

Best-by / use-by date

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

  • 05
  • 2026
  • 12
  • 2026. — 29
  • 542 bottles

NDC number

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

  • 60219-2348-5

Package size

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

  • 50 mg
  • 500 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 Potency

Amneal Pharmaceuticals, LLC — 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. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  3. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  4. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.

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?

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH). Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AM230987, 2026; best-by date 05 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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