Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION Recalled by Akorn, Inc. Due to Failed Dissolution Specifications: Out of specification for dissolution...

Date: March 17, 2015
Company: Akorn, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Akorn, Inc. directly.

Affected Products

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Quantity: 8,400 unit dose cups (20 mL each)

Why Was This Recalled?

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Akorn, Inc.

Akorn, Inc. has 176 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report