Tacrolimus Capsules — Class II drug recall D-0330-2023
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2023-03-01, distributed nationwide. Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containin
| Recall number | D-0330-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2023-02-08 |
| Classified | 2023-02-21 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 4,320 bottles |
| Reason classes | labeling |
| 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 | C2106445 |
| Expiration dates | 2024-03 |
Product
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
Reason for recall
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg 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-0330-2023. 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.