FDA Drug recall D-0330-2023
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA
- FDA Drug
- Class II
- ongoing
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class II recall of Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA by Dr Reddy S Laboratories, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0330-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-08 |
| Published | 2023-03-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
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.
Identifiers
| ndc | 55111-525-30 |
|---|---|
| ndc | 55111-525-01 |
| ndc | 55111-525-05 |
| ndc | 55111-525-79 |
| ndc | 55111-525-78 |
| ndc | 55111-526-30 |
| ndc | 55111-526-01 |
| ndc | 55111-526-05 |
| ndc | 55111-526-79 |
| ndc | 55111-526-78 |
| ndc | 55111-527-30 |
| ndc | 55111-527-01 |
| ndc | 55111-527-05 |
| ndc | 55111-527-79 |
| ndc | 55111-527-78 |
| code_info | Lot # C2106445; Exp. 03/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0330-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.