FDA Recall Amoxicillin

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Amoxicillin with NDC 0781-6157 was initiated on 04-13-2022 as a Class II recall due to cgmp deviations: temperature abuse The latest recall number for this product is D-1025-2022 and the recall is currently terminated as of 11-30-2023 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1025-202204-13-202206-15-2022Class II12 bottlesAmoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01Terminated
D-0166-202401-26-202201-03-2024Class II2 unitsAMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20Completed
D-268-201304-18-201305-01-2013Class II8286 x 30 ct, 37108 x 500 ct. bottlesAmoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.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.