Lansoprazole Delayed-Release Orally Disintegrating Tablets — Class II drug recall D-0853-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2022-05-11, distributed in OH. Failed Dissolution Specifications
| Recall number | D-0853-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2022-04-15 |
| Classified | 2022-05-05 |
| Reported by FDA | 2022-05-11 |
| Terminated | 2023-11-07 |
| Distributed | OH |
| Quantity | 252 blister |
| Reason classes | specification failure |
| NDC | 43598-0560, 43598-0560-78, 43598-0560-79, 43598-0561, 43598-0561-78, 43598-0561-79 |
| Lot numbers | T2000645 |
| Expiration dates | 2022-07 |
Product
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
Reason for recall
Failed Dissolution Specifications
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-0853-2022. 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.