US Drug Recall Register
Class III · Low risk Terminated Initiated Oct 23, 2023 (3 years ago)

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).

What was recalled

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
68462-390-30
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0112-2024

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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