Tacrolimus Capsules — Class II drug recall D-383-2014
Terminated recall by Sandoz Incorporated, reported 2014-01-01, distributed nationwide. Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured p
| Recall number | D-383-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2013-10-22 |
| Classified | 2013-12-20 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 12,521 bottles |
| NDC | 00781-2102, 00781-2102-01, 00781-2103, 00781-2103-01, 00781-2104, 00781-2104-01 |
| Lot numbers | 06/14, DE9898, DE9900, DE9903, DE9908, DE9911 |
Product
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Reason for recall
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
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-383-2014. 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.