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Amoxicillin

FDA recalls

7 rows

Date	Company and reason	Class
Apr 12, 2022	McKesson Medical-Surgical Inc. Corporate Office cGMP deviations: Temperature abuse	Class II · Terminated
Jan 25, 2022	Cardinal Healthcare CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.	Class II · Terminated
Nov 3, 2016	West-Ward Pharmaceuticals Corp. Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.	Class III · Terminated
Jun 23, 2016	Teva North America Superpotent drug: Out of specification test result for assay during stability testing.	Class II · Terminated
Jun 17, 2013	Teva Pharmaceuticals USA, Inc. Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.	Class III · Terminated
Apr 25, 2013	Teva Pharmaceuticals USA, Inc. Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.	Class III · Terminated
Apr 17, 2013	Sandoz Incorporated Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.	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).