Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amlodipine Besylate Tablets Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Due to CGMP Deviations: Pharmaceuticals were produced and distributed with...
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
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Quantity: a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons
Why Was This Recalled?
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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