Mycophenolic Acid Delayed-release Tablets — Class II drug recall D-1111-2015
Terminated recall by Mylan Lab Inc, reported 2015-06-10, distributed nationwide. Failed Dissolution Specifications: Low out of specification dissolution results.
| Recall number | D-1111-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Lab Inc, Canonsburg, PA, United States |
| Recall initiated | 2015-05-20 |
| Classified | 2015-05-29 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-10-21 |
| Distributed | Nationwide (US) |
| Quantity | 7,722 bottles |
| Reason classes | specification failure |
| NDC | 00378-4201-78 |
| Lot numbers | 08/16, 3059043 |
Product
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
Reason for recall
Failed Dissolution Specifications: Low out of specification dissolution results.
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-1111-2015. 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.