FDA Drug recall D-452-2013
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Man…
- FDA Drug
- Class III
- terminated
- Published 2013-05-29
On 2013-05-29 the FDA classified a Class III recall of Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Man… by Mylan Institutional D B A Udl Laboratories, citing failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-452-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-15 |
| Published | 2013-05-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
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, NDC 51079-020-03.
Reason
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Identifiers
| code_info | Lot No: 3037382, Exp 09/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-452-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.