Medications & Supplements/Prescription Drugs

Amneal Sulfamethoxazole and Trimethoprim Tablets Recalled for Contamination

Agency Publication Date: June 11, 2025

Summary

Amneal Pharmaceuticals is recalling 6,396 bottles of Sulfamethoxazole and Trimethoprim (400 mg/80 mg) tablets due to microbial contamination. The affected tablets may develop visible black spots on their surface. This recall includes both 100-count and 500-count bottles distributed nationwide in the United States. Consumers should consult their doctor or pharmacist immediately if they have used this medication.

Risk

The tablets may contain microbial contamination, which can lead to serious infections, particularly in patients with compromised immune systems. The contamination is visibly identifiable as black spots on the medication.

What You Should Do

This recall affects Amneal Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg) sold in 100-count bottles (NDC 65162-271-10) and 500-count bottles (NDC 65162-271-50).
Check your bottle for lot numbers AM241019, AM241020, or AM241019A, all with an expiration date of 06/30/2027.
Inspect tablets for the presence of visible black spots.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg (100 Tablets)

Variants: 400 mg/80 mg, 100 Tablets, Tablet

Lot Numbers:

AM241019 (Exp 06/30/2027)

AM241020 (Exp 06/30/2027)

NDC:

65162-271-10

Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India.

Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg (500 Tablets)

Variants: 400 mg/80 mg, 500 Tablets, Tablet

Lot Numbers:

AM241019A (Exp 06/30/2027)

NDC:

65162-271-50

Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India.

Product Images

Labeling, Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, 100 Tablets

Labeling, Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, 500 Tablets

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96985

Status: Active

Manufacturer: Amneal Pharmaceuticals, LLC

Manufactured In: India

Units Affected: 6396 bottles

Distributed To: Nationwide

Agency Last Updated: June 23, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Amneal Sulfamethoxazole and Trimethoprim Tablets (400 mg/80 mg) sold in 100-count bottles (NDC 65162-271-10) and 500-count bottles (NDC 65162-271-50).

Check your bottle for lot numbers AM241019, AM241020, or AM241019A, all with an expiration date of 06/30/2027.

Inspect tablets for the presence of visible black spots.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg (100 Tablets)

Variants: 400 mg/80 mg, 100 Tablets, Tablet

Lot Numbers:

AM241019 (Exp 06/30/2027)

AM241020 (Exp 06/30/2027)

NDC:

65162-271-10

Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India.

Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg (500 Tablets)

Variants: 400 mg/80 mg, 500 Tablets, Tablet

Lot Numbers:

AM241019A (Exp 06/30/2027)

NDC:

65162-271-50

Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India.