FDA Drug recall D-0318-2024
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distribute…
- FDA Drug
- Class II
- terminated
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distribute… by Natco Pharma, citing 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 detai….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0318-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-02-01 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Natco Pharma |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot # 411987 Exp: 05/2025 |
|---|
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-0318-2024%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.