CLASS III Drug recall · Reported 29 May 2013 · FDA Enforcement Report
Budesonide Capsules, 3 mg, Enteric Coated recalled
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Budesonide Capsules, 3 mg, Enteric Coated, distributed nationwide in the US. The recall was initiated on 15 May 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-452-2013
- FDA event ID
- 65115
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 May 2013
- FDA classified
- 22 May 2013
- Reported
- 29 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 15 May 2013 | Recall initiated by company | |
| 22 May 2013 | Classified by FDA | +7 days |
| 29 May 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Which lots are affected?
Lot No: 3037382, Exp 09/13
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other Budesonide recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 0.5mg/-dose ampules per, five recalledBudesonide | Cipla USA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide, USP (Micronized), 500 mg recalled by Medisca | Medisca | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets 9mg recalledBudesonide | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets, 9 mg recalled | Golden State Medical Supply | Potency & Assay | IL |