FDA Recall Cephalexin

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Cephalexin with NDC 0093-4175 was initiated on 08-24-2020 as a Class II recall due to cgmp deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. The latest recall number for this product is D-0012-2021 and the recall is currently terminated as of 12-16-2021 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0012-202108-24-202009-16-2020Class II103,940 bottlesCephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.Terminated
D-1566-202008-24-202009-16-2020Class II38,487 bottlesCephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.Terminated
D-0013-202108-24-202009-16-2020Class II1,467,535 bottlesCephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.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.