Budesonide Capsules — Class III drug recall D-452-2013
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2013-05-29, distributed nationwide. Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specif
| Recall number | D-452-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-05-22 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2015-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,621 boxes |
| Reason classes | specification failure |
| NDC | 51079-0020-03 |
| Lot numbers | 09/13, 3037382 |
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 for recall
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-452-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.