FDA Recall Hydroxyzine Hydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on December 11th, 2013 and classified as a Class II recall due to good manufacturing practices deviations: the product has an active pharmaceutical ingredient from an unapproved source. This recall is currently terminated, and the associated recall number is recall number is D-1032-2014. It pertains to Hydroxyzine Hydrochloride identified by 10702-012 as of 08-03-2015 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-1032-2014 | 12-11-2013 | 01-29-2014 | 104551 bottles | HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10. | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | Terminated |
| D-1031-2014 | 12-11-2013 | 01-29-2014 | 249,096 bottles | HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10. | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | Terminated |
| D-1030-2014 | 12-11-2013 | 01-29-2014 | 14664 bottles | HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01. | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | 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.
