Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zyd…

Recall date

November 14, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0102-2025

FDA classification

Class III

Brand / firm

Zydus Pharmaceuticals (USA) Inc

Sold / distributed

USA Nationwide.

Why it was recalled

Labeling: Not Elsewhere Classified - Wrong NDC number

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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