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Drug FDA Class III Ongoing Foreign material

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

Rising Pharma Holding, Inc. Published Jun 12, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Rising Pharma Holding, Inc. or your place of purchase with questions, and see the source record below for full details.
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.

Hazards

Pantoprazole Tablet · primary

Affected products (1)

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

PREGABALIN · N/A

NDC: 64980-410, 64980-411, 64980-412, 64980-413, 64980-414, 64980-415, 64980-416, 64980-417, 64980-410-09, 64980-410-10, 64980-410-01, 64980-411-09, 64980-411-10, 64980-411-01, 64980-412-09, 64980-412-10, 64980-412-01, 64980-413-09, 64980-413-10, 64980-413-01, 64980-414-09, 64980-414-10, 64980-414-01, 64980-415-09, 64980-415-10, 64980-415-01, 64980-416-09, 64980-416-10, 64980-416-01, 64980-417-09, 64980-417-10, 64980-417-01
Lot codes: 23132611
Code info: Lot: 23132611, Exp 07/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    May 16, 2024
  2. Published
    Jun 12, 2024
Recall number
D-0541-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.