Lansoprazole Delayed-Release Capsules USP — Class II drug recall D-0318-2024
Terminated recall by NATCO Pharma Limited, reported 2024-02-14, distributed nationwide. CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, ca
| Recall number | D-0318-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NATCO Pharma Limited, Rangareddy, India |
| Recall initiated | 2024-02-01 |
| Classified | 2024-02-08 |
| Reported by FDA | 2024-02-14 |
| Terminated | 2026-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 4,260 bottles |
| Reason classes | cgmp, packaging |
| NDC | 16571-0742-41 |
| Lot numbers | 411987 |
| Expiration dates | 2025-05 |
Product
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Reason for recall
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
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-0318-2024. 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.