FDA Recall Cephalexin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on August 24th, 2020 and classified 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. This recall is currently terminated, and the associated recall number is recall number is D-0012-2021. It pertains to Cephalexin identified by 0093-4177 as of 12-16-2021 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0012-2021 | 08-24-2020 | 09-16-2020 | 103,940 bottles | Cephalexin 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. | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Terminated |
| D-1566-2020 | 08-24-2020 | 09-16-2020 | 38,487 bottles | Cephalexin 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. | Sub-Potent Drug: Out of specification test results for potency (below specification). | Terminated |
| D-0013-2021 | 08-24-2020 | 09-16-2020 | 1,467,535 bottles | Cephalexin 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. | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
