Esomeprazole Magnesium Delayed-Release Capsules Recalled for Failed Quality Specifications
Mylan Institutional is recalling Esomeprazole Magnesium Delayed-Release Capsules 40 mg due to failed impurity specifications found during stability testing, affecting 885 cartons nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a quality control failure (failed impurity specifications) with no reported illnesses or injuries. Per the rubric, a Class II recall without hospitalization reports or reported adverse events warrants a Moderate severity score.
Plain-English summary
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 capsules each per carton). The product is manufactured for Mylan Pharmaceuticals Inc. and distributed nationwide in the United States. The recall affects 885 cartons.
The recall was initiated due to failed impurity specifications identified during stability testing. During 12-month stability testing at room temperature, an out-of-specification (OOS) result was obtained for an individual impurity, indicating that the impurity level exceeded the acceptable limits. The affected lot numbers are: 3110437, 3111409, and 3110785 (expiration date 7/31/2022) and 3112173 (expiration date 11/30/2022).
This is a Class II recall issued by the U.S. Food and Drug Administration under Recall Number D-0861-2022.
The recalled product
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Category
- Drug
- Hazard
- impurity
- quality-control-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 3110437
- 3111409
- 3110785
- Exp. Date 7/31/2022
- 3112173
- Exp. Date 11/30/2022
Distribution
Distributed nationwide across the United States.
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