FDA Recall Amoxicillin

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Amoxicillin with NDC 0093-4160 was initiated on 01-26-2022 as a Class II recall due to cgmp deviations: products were exposed to temperatures outside of the products labeled storage conditions. The latest recall number for this product is D-0165-2024 and the recall is currently completed .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0165-202401-26-202201-03-2024Class II3 unitsAMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73Completed
D-1470-201606-24-201608-31-2016Class II53,328 bottlesAmoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76Terminated
D-803-201306-18-201307-24-2013Class III109,080 BottlesAmoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.Terminated
D-598-201304-26-201306-19-2013Class III758,554 bottlesAmoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.