Tacrolimus Ointment — Class III drug recall D-1304-2022
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2022-08-10, distributed nationwide. Defective Container: Tube split from side seam
| Recall number | D-1304-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2022-07-11 |
| Classified | 2022-08-04 |
| Reported by FDA | 2022-08-10 |
| Distributed | Nationwide (US) |
| Quantity | 654,756 tubes |
| Reason classes | packaging |
| NDC | 68462-0534, 68462-0534-35, 68462-0534-65, 68462-0534-94, 68462-0881, 68462-0881-35, 68462-0881-65, 68462-0881-94 |
| Expiration dates | 2022-06, 2022-07, 2022-08, 2022-09, 2022-10, 2022-11, 2022-12, 2023-01, 2023-02, 2023-03, 2023-04, 2023-05, 2023-06, 2023-07, 2023-08, 2023-09, 2023-10, 2023-11, 2023-12, 2024-01, 2024-02, 2024-03 |
Product
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Reason for recall
Defective Container: Tube split from side seam
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-1304-2022. 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.