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Gabapentin & pregabalin

FDA recalls

14 rows

DateCompany and reasonClass
Oct 9, 2025The Harvard Drug Group LLC
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity.		Class II · Ongoing
Jun 18, 2025The Harvard Drug Group LLC
Defective container; blister packaging inadequately sealed.		Class II · Ongoing
Mar 12, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations		Class II · Ongoing
Mar 3, 2025Sun Pharmaceutical Industries Inc
Cross Contamination		Class III · Ongoing
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
Apr 23, 2023The Harvard Drug Group
Product mixup: one foreign tablet found in product.		Class III · Terminated
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
May 13, 2020Invagen Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.		Class III · Terminated
Mar 17, 2020Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed		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
Dec 14, 2014Actavis Elizabeth LLC
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.		Class II · Terminated
Oct 16, 2014Aurobindo Pharma USA Inc
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.		Class II · Terminated
Apr 4, 2013Glenmark Generics Inc., USA
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.		Class III · 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).