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Pregabalin

FDA recalls

4 rows

DateCompany and reasonClass
May 15, 2024Rising Pharma Holding, Inc.
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.		Class III · Ongoing
Oct 21, 2021Sun Pharmaceutical Industries Inc
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.		Class II · Terminated
Mar 14, 2021Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.		Class II · Terminated
Jan 10, 2016Pfizer Inc.
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).