Class II U.S. Food and Drug Administration

Amneal Pharmaceuticals, LLC Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil

Recall published 1+ years ago

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

The hazard: Foreign material — foreign objects

The company found foreign objects in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

What the notice says: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

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-0615-2025
Published
September 10, 2025
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
60,072 100-count, 73,054 500-count bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27.

Products covered by this recall

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Check your product

The notice names 25 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

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

  • 01
  • 31
  • 2027
  • AM240680
  • 06
  • 30
  • AM241191
  • AM240301
  • AM240300
  • 04
  • AM240678
  • AM240679
  • 27
  • AM241086
  • AM24
  • 27. — 60
  • 072 100-count
  • 73
  • 054 500-c

NDC number

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

  • 65162-272-10
  • 65162-272-50

Package size

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

  • 800 mg
  • 160 mg
  • 100 count
  • 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 Foreign material

Amneal Pharmaceuticals, LLC — The company found foreign objects in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  3. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  4. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

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?

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 01 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?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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