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.

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg Recalled by Teva Pharmaceuticals USA Due to Failed Dissolution Specification: Dissolution results are below specification...

Date: January 18, 2022
Company: Teva Pharmaceuticals USA
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 Teva Pharmaceuticals USA directly.

Affected Products

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01

Quantity: 6205 100-count bottles

Why Was This Recalled?

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA

Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.

Related Recalls

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