FDA Drug recall D-0541-2024
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufacture…
- FDA Drug
- Class III
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class III recall of Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufacture… by Rising Pharma Holding, citing presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during pa….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0541-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-05-16 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharma Holding |
| Distribution | US |
Product
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
Reason
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Identifiers
| ndc | 64980-410-09 |
|---|---|
| ndc | 64980-410-10 |
| ndc | 64980-410-01 |
| ndc | 64980-411-09 |
| ndc | 64980-411-10 |
| ndc | 64980-411-01 |
| ndc | 64980-412-09 |
| ndc | 64980-412-10 |
| ndc | 64980-412-01 |
| ndc | 64980-413-09 |
| ndc | 64980-413-10 |
| ndc | 64980-413-01 |
| ndc | 64980-414-09 |
| ndc | 64980-414-10 |
| ndc | 64980-414-01 |
| ndc | 64980-415-09 |
| ndc | 64980-415-10 |
| ndc | 64980-415-01 |
| ndc | 64980-416-09 |
| ndc | 64980-416-10 |
| ndc | 64980-416-01 |
| ndc | 64980-417-09 |
| ndc | 64980-417-10 |
| ndc | 64980-417-01 |
| code_info | Lot: 23132611, Exp 07/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0541-2024%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.