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.

Quetiapine Tablets USP 400 mg Recalled by Ascend Laboratories LLC Due to Presence of Foreign Substance; metal shard found in...

Date: November 14, 2018
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

Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1

Quantity: N/A

Why Was This Recalled?

Presence of Foreign Substance; metal shard found in tablet

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