Yes — there is an active recall. 4 ongoing FDA recalls mention Esomeprazole (17 total). Check the affected lots below.
Most common reason: Impurity / degradation (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Esomeprazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Labeling: Not Elsewhere Classified - Wrong NDC number
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).
CGMP Deviations: product held outside appropriate storage temperature conditions.
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Discoloration: product contains brown pellets
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
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