The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-452-2013·Announced 2013-05-29

Mylan Recalls Budesonide Capsules Due to Dissolution Testing Failures

Mylan Institutional, Inc. is recalling 1,621 boxes of Budesonide Capsules, 3 mg, because routine stability testing showed out-of-specification dissolution results.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 1,621 boxes of Budesonide Capsules, 3 mg, Enteric Coated. The product is packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box and is available by prescription only. The specific lot number is 3037382 with an expiration date of 09/13.

The recall was initiated because routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. This indicates that the capsules may not release the medication as intended.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for disposal or replacement.

The recalled product

Product
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…
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Prescription Medication
Hazard
Affected units
1,621

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 (2)

  • Lot No: 3037382
  • Exp 09/13

Distribution

Distributed nationwide across the United States.

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