Pregabalin Capsules 50mg — Class III drug recall D-0541-2024
Ongoing recall by Rising Pharma Holding, Inc., reported 2024-06-12, distributed nationwide. Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP),
| Recall number | D-0541-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rising Pharma Holding, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2024-05-16 |
| Classified | 2024-06-04 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| NDC | 64980-0410, 64980-0410-01, 64980-0410-09, 64980-0410-10, 64980-0411, 64980-0411-01, 64980-0411-09, 64980-0411-10, 64980-0412, 64980-0412-01, 64980-0412-09, 64980-0412-10, 64980-0413, 64980-0413-01, 64980-0413-09, 64980-0413-10, 64980-0414, 64980-0414-01, 64980-0414-09, 64980-0414-10, 64980-0415, 64980-0415-01, 64980-0415-09, 64980-0415-10, 64980-0416 and 7 more |
| Lot numbers | 23132611 |
| Expiration dates | 2026-07-31 |
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 for recall
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.
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-0541-2024. 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.