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.

Cephalexin for Oral Suspension Recalled by Ascend Laboratories LLC Due to CGMP Deviations: Individual Unidentified impurities results of the...

Date: January 22, 2021
Company: Ascend Laboratories LLC
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 Ascend Laboratories LLC directly.

Affected Products

Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

Quantity: 23,436 200 mL bottles

Why Was This Recalled?

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ascend Laboratories LLC

Ascend Laboratories LLC has 15 total recalls tracked by RecallDetector.

Related Recalls

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