Class II U.S. Food and Drug Administration

Major Pharmaceuticals and Rugby Laboratories Sulfamethoxazole and Trimethoprim 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 by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

The hazard: Foreign material — foreign objects

This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

What the notice says: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) 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-0625-2025
Published
September 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Major Pharmaceuticals and Rugby Laboratories
Product type
Prescription & OTC drugs
Units affected
N/A
Distribution
Nationwide
Made in
United States
Lot / code info
Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027

Products covered by this recall

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).

Check your product

The notice names 9 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.

  • N02309

Best-by / use-by date

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

  • 03
  • 31
  • 2027
  • 2027 — N

NDC number

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

  • 55154-7895-0
  • 0904-2725-61

Package size

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

  • 800 mg
  • 160 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 Foreign material

Major Pharmaceuticals and Rugby Laboratories — This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  3. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  4. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — 341 Mason Rd, La Vergne, TN, 37086-3606

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 Major Pharmaceuticals and Rugby Laboratories prescription &… recalled?

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) 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 by manufacturer (Amneal Pharmaceuticals LLC) 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: lot code N02309; best-by date 03 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?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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