FDA Recall D-0541-2024

Rising Pharma Holding, Inc. · East Brunswick, NJ

Class III Ongoing 728 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot: 23132611, Exp 07/31/2026

Quantity: N/A

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.

Recall record

Recall number: D-0541-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA
Recall initiated: 2024-05-16
Classified by FDA Center: 2024-06-04
FDA published: 2024-06-12
Recalling firm: Rising Pharma Holding, Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): PREGABALIN
Generic name(s): PREGABALIN
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 64980-410, 64980-411, 64980-412, 64980-413, 64980-414, 64980-415, 64980-416, 64980-417
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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