Tacrolimus Capsules — Class II drug recall D-0219-2024
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2024-01-17, distributed nationwide. Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsu
| Recall number | D-0219-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2023-12-15 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Terminated | 2024-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 8,280 bottles |
| NDC | 55111-0525, 55111-0525-01, 55111-0525-05, 55111-0525-30, 55111-0525-78, 55111-0525-79, 55111-0526, 55111-0526-01, 55111-0526-05, 55111-0526-30, 55111-0526-78, 55111-0526-79, 55111-0527, 55111-0527-01, 55111-0527-05, 55111-0527-30, 55111-0527-78, 55111-0527-79 |
| Lot numbers | C2307275 |
| Expiration dates | 2026-01-20 |
Product
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Reason for recall
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
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-0219-2024. 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.