Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Esomeprazole Magnesium Delayed-Release Capsules Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Due to Failed Impurities/Degradation Specifications: OOS result was obtained for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Institutional, Inc. (d.b.a. UDL Laboratories) directly.
Affected Products
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 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 42292-009-16
Quantity: 555 cartons
Why Was This Recalled?
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report