Elevated risk U.S. Food and Drug Administration

Amneal Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg recall: Microbial contamination

Recall published 1+ years ago

Microbial contamination

Amneal Prescription & OTC drugs — recalled prescription & otc drugsAmneal Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

What the notice says: Risk Statement: Oral products contaminated with Aspergillus may result in serious and life-threatening infections.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

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

Published
June 2, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Amneal
Product type
Prescription & OTC drugs
Distribution
Nationwide
Reports of harm
To date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall.

Products covered by this recall

Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

What the company announced

Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint.

Risk Statement: Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections. To date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall.

The recalled product was distributed nationwide to wholesalers/distributors between the dates of 12/4/2024 to 5/15/2025 only.

The product is indicated for the treatment of Urinary tract infections caused by susceptible strains of the following organisms: Escherichia Coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. Acute otitis media in pediatric patients. Acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae . Enteritis caused by susceptible strains of Shigella flexneri and traveler's diarrhea in adults.

Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg is packaged in 100 tablet count and 500 tablet count bottles. This recall pertains only to the 400 mg/80 mg strength and only to the listed Lots below. The lot number can be found on the Amneal bottle label or consult your pharmacy if you received a pharmacy vial. No other Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg lots are impacted.

  • Lot Number: AM241019 · NDC Number: 65162-271-10 · Expiration date: 06/2027 · Date of First Distribution: 12/4/2024 · Bottle Pack Size: 100 count
  • Lot Number: AM241019A · NDC Number: 65162-271-50 · Expiration date: 06/2027 · Date of First Distribution: 12/4/2024 · Bottle Pack Size: 500 count
  • Lot Number: AM241020 · NDC Number: 65162-271-10 · Expiration date: 06/2027 · Date of First Distribution: 12/4/2024 · Bottle Pack Size: 100 count

Amneal is notifying its customers by UPS and is arranging for return of all recalled products. Wholesalers/distributors are being asked to notify their customers of the recall and provide instructions to contact Amneal for the return of the recalled products to Amneal. Retailers are being asked to notify their customers and instruct consumers to contact Amneal directly for assistance with return of any recalled product and reimbursement information.

Individuals with questions regarding this recall can contact Amneal Pharmaceuticals by:

Phone: 833-582-0812 Monday-Friday, 8:00 am-5:00 pm, EST

Fax: 631-983-2595

E-mail to: [email protected]

For Medical Inquiries or to report Adverse Events, or quality problems experienced with the use of this product, please contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or e-mail at [email protected] .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

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.

  • 400 mg/80
  • AM241019
  • AM241019A
  • AM241020

Best-by / use-by date

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

  • 06/2027

Package size

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

  • 400 mg
  • 80 mg
  • 100 count
  • 500 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Amneal — A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

  1. Stop eating it and keep it separate from other food.
  2. Clean and sanitise the fridge shelf, container or surface it was stored on.
  3. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  4. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Company contact: Amneal Pharmaceutical LLC — Consumers: Amneal Drug Safety, 1-833-582-0812, [email protected]

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 — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Amneal prescription & otc drugs recalled?

Microbial contamination Risk Statement: Oral products contaminated with Aspergillus may result in serious and life-threatening infections.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 400 mg/80, AM241019, AM241019A; best-by date 06/2027. 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 keep it separate from other food.

Can I get my money back?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

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