Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Budesonide Capsules Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Due to Failed Dissolution Specifications: Routine stability testing at the...
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
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.
Quantity: 1,621 boxes
Why Was This Recalled?
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
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