Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg Recalled by Zydus Pharmaceuticals (USA) Inc Due to Labeling: Not Elsewhere Classified - Wrong NDC number

Date: November 14, 2024
Company: Zydus Pharmaceuticals (USA) Inc
Status: Ongoing
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 Zydus Pharmaceuticals (USA) Inc directly.

Affected Products

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

Quantity: 4404 packs

Why Was This Recalled?

Labeling: Not Elsewhere Classified - Wrong NDC number

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.

Related Recalls

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