34 FDA recalls mention Omeprazole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Omeprazole.
Reason Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Reason Subpotent Drug: Out of specification for assay
Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Reason Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Reason Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Reason CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Reason Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Reason Discoloration: product contains brown pellets
Reason Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Reason Lack of Processing Controls.
Reason Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per…
Reason Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per…
Reason Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules…
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.