Tacrolimus Capsules — Class III drug recall D-1057-2020
Terminated recall by Mylan Pharmaceuticals Inc., reported 2020-04-01, distributed nationwide. Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bott
| Recall number | D-1057-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2020-03-23 |
| Classified | 2020-03-24 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-07-07 |
| Distributed | Nationwide (US) |
| Quantity | 3,816 botlles |
| NDC | 00378-2045, 00378-2045-01, 00378-2046, 00378-2046-01, 00378-2047, 00378-2047-01 |
| Lot numbers | 3105410, 3106268 |
| Expiration dates | 2020-09 |
Product
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Reason for recall
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
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-1057-2020. 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.