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

FDA recall notice · announced June 12, 2024 · Rising Pharma Holding

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 23132611, Exp 07/31/2026
Quantity: N/A
Status: Ongoing
Products in this recall event:
- 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 6498 (D-0541-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.