Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg — Class II drug recall D-0075-2021
Terminated recall by Zydus Pharmaceuticals (USA) Inc, reported 2020-11-11, distributed nationwide. Failed Dissolution Specification
| Recall number | D-0075-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2020-10-27 |
| Classified | 2020-11-10 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2022-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 7,908 units |
| Reason classes | specification failure |
| NDC | 68382-0771, 68382-0771-30, 68382-0771-77, 68382-0772, 68382-0772-30, 68382-0772-77 |
| Lot numbers | M005682 |
| Expiration dates | 2022-03 |
Product
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77
Reason for recall
Failed Dissolution Specification
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-0075-2021. 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.