Medications & Supplements/Prescription Drugs

Amneal Sulfamethoxazole-Trimethoprim and Chlorpromazine Tablets Recalled

Agency Publication Date: September 4, 2025

Summary

Amneal Pharmaceuticals is recalling approximately 98,716 bottles of Sulfamethoxazole and Trimethoprim (800mg/160mg) and various strengths of Chlorpromazine Hydrochloride (25mg to 200mg) tablets. The recall was issued because a microorganism was discovered on a specific batch of the polyester coil used inside the medication bottles during packaging. Although testing found no contamination on the actual tablets, the company is voluntarily removing the products to ensure consumer safety. These medications are used to treat bacterial infections and certain mental/mood disorders.

Risk

The presence of a microorganism in the packaging material could potentially introduce contaminants to the medication. While no contamination was found on the tablets themselves, the use of affected products could pose a health risk, particularly for patients with weakened immune systems.

What You Should Do

This recall affects Sulfamethoxazole and Trimethoprim Tablets (Double Strength) and Chlorpromazine Hydrochloride Tablets in 25 mg, 50 mg, 100 mg, and 200 mg strengths sold in 100-count and 500-count white plastic bottles.
Identify if your medication is affected by checking the National Drug Code (NDC) and lot number printed on the bottle's label. See the Affected Products section below for the full list of affected codes.
If you have health concerns regarding this medication, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

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 800mg/160mg, Double Strength

Variants: 800mg/160mg, Double Strength, Oral Tablet

Lot Numbers:

AM240173 (Exp 01/31/2027)

AM240680 (Exp 05/31/2027)

AM 240921 (Exp 06/30/2027)

AM241191 (Exp 08/31/2027)

AM240176 (Exp 01/31/2027)

AM240177 (Exp 01/31/2027)

AM240301 (Exp 02/28/2027)

AM240300 (Exp 02/28/2027)

AM240676 (Exp 04/30/2027)

AM240677 (Exp 04/30/2027)

AM240678 (Exp 05/30/2027)

AM240679 (Exp 05/30/2027)

AM240922 (Exp 6/30/27)

AM240923 (Exp 6/30/27)

AM240924 (Exp 6/30/27)

AM240925 (Exp 6/30/27)

AM241086 (Exp 7/31/27)

AM241087 (Exp 8/31/27)

AM241088 (Exp 8/31/27)

NDC:

65162-272-10

65162-272-50

Packaged as 100-count and 500-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg

Variants: 25 mg, Oral Tablet

Lot Numbers:

AM240617 (Exp 04/30/2027)

AM240618 (Exp 04/30/2027)

NDC:

69238-1056-1

100-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 50 mg

Variants: 50 mg, Oral Tablet

Lot Numbers:

AM240147 (Exp 01/31/2027)

AM240148 (Exp 01/31/2027)

AM240664 (Exp 04/30/2027)

AM240665 (Exp 04/30/2027)

NDC:

69238-1058-1

100-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg

Variants: 100 mg, Oral Tablet

Lot Numbers:

AM240334 (Exp 02/28/2027)

AM240335 (Exp 02/28/2027)

AM241031 (Exp 06/30/2027)

NDC:

69238-1060-1

100-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg

Variants: 200 mg, Oral Tablet

Lot Numbers:

AM240336 (Exp 02/28/2027)

AM240337 (Exp 02/28/2027)

NDC:

69238-1062-1

100-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97438

Status: Active

Manufacturer: Amneal Pharmaceuticals, LLC

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 5 products (60,072 100-count, 73,054 500-count bottles; 7,228 100-count bottles; 13,130 100-count bottles; 14,923 100-count bottles; 3,363 100-count bottles)

Distributed To: Nationwide

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 · 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 Sulfamethoxazole and Trimethoprim Tablets (Double Strength) and Chlorpromazine Hydrochloride Tablets in 25 mg, 50 mg, 100 mg, and 200 mg strengths sold in 100-count and 500-count white plastic bottles.

Identify if your medication is affected by checking the National Drug Code (NDC) and lot number printed on the bottle's label. See the Affected Products section below for the full list of affected codes.

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

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

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 800mg/160mg, Double Strength

Variants: 800mg/160mg, Double Strength, Oral Tablet

Lot Numbers:

AM240173 (Exp 01/31/2027)

AM240680 (Exp 05/31/2027)

AM 240921 (Exp 06/30/2027)

AM241191 (Exp 08/31/2027)

AM240176 (Exp 01/31/2027)

AM240177 (Exp 01/31/2027)

AM240301 (Exp 02/28/2027)

AM240300 (Exp 02/28/2027)

AM240676 (Exp 04/30/2027)

AM240677 (Exp 04/30/2027)

AM240678 (Exp 05/30/2027)

AM240679 (Exp 05/30/2027)

AM240922 (Exp 6/30/27)

AM240923 (Exp 6/30/27)

AM240924 (Exp 6/30/27)

AM240925 (Exp 6/30/27)

AM241086 (Exp 7/31/27)

AM241087 (Exp 8/31/27)

AM241088 (Exp 8/31/27)

NDC:

65162-272-10

65162-272-50

Packaged as 100-count and 500-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg

Variants: 25 mg, Oral Tablet

Lot Numbers:

AM240617 (Exp 04/30/2027)

AM240618 (Exp 04/30/2027)

NDC:

69238-1056-1

100-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 50 mg

Variants: 50 mg, Oral Tablet

Lot Numbers:

AM240147 (Exp 01/31/2027)

AM240148 (Exp 01/31/2027)

AM240664 (Exp 04/30/2027)

AM240665 (Exp 04/30/2027)

NDC:

69238-1058-1

100-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg

Variants: 100 mg, Oral Tablet

Lot Numbers:

AM240334 (Exp 02/28/2027)

AM240335 (Exp 02/28/2027)

AM241031 (Exp 06/30/2027)

NDC:

69238-1060-1

100-count bottles.

Product: Chlorpromazine Hydrochloride Tablets, USP, 200 mg

Variants: 200 mg, Oral Tablet

Lot Numbers:

AM240336 (Exp 02/28/2027)

AM240337 (Exp 02/28/2027)

NDC:

69238-1062-1

100-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97438

Status: Active

Manufacturer: Amneal Pharmaceuticals, LLC

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 5 products (60,072 100-count, 73,054 500-count bottles; 7,228 100-count bottles; 13,130 100-count bottles; 14,923 100-count bottles; 3,363 100-count bottles)

Distributed To: Nationwide