FDA Drug recall D-0074-2021
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Hea…
- FDA Drug
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Hea… by Zydus Pharmaceuticals Usa, citing failed Dissolution Specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0074-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-27 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 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 68382-771-77
Reason
Failed Dissolution Specification
Identifiers
| ndc | 68382-771-30 |
|---|---|
| ndc | 68382-771-77 |
| ndc | 68382-772-30 |
| ndc | 68382-772-77 |
| code_info | Lot # M005681, EXP 3/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0074-2021%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.