Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Benzhydrocodone and Acetaminophen Tablets Recalled by KVK-Tech, Inc. Due to Failed Impurities/Degradation Specifications; out of specification results obtained...

Date: December 18, 2020
Company: KVK-Tech, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact KVK-Tech, Inc. directly.

Affected Products

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

Quantity: 528 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About KVK-Tech, Inc.

KVK-Tech, Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report