Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Hydrocodone Bitartrate and Acetaminophen Tablets Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Due to Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in...
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
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
Quantity: 3,407 cartons
Why Was This Recalled?
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
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