Mylan — Class II drug recall D-066-2013
Terminated recall by Mylan LLC., reported 2012-12-05. Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
| Recall number | D-066-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan LLC., Caguas, PR, United States |
| Recall initiated | 2012-06-29 |
| Classified | 2012-11-26 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2017-04-13 |
| Quantity | 15,181 bottles |
| Reason classes | specification failure |
| NDC | 00378-2045, 00378-2045-01, 00378-2046, 00378-2046-01, 00378-2047, 00378-2047-01 |
| Lot numbers | 2002157, 3027684, 3027688, 5/13, 6/13, 9/12 |
Product
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Reason for recall
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
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-066-2013. 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.