KVK-Tech Benzhydrocodone and Acetaminophen Tablets Recall

Why it was 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

Product description

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

Lot numbers, UPCs & expiration codes

Batch# 15892A, Exp, 2021-FEB

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0224-2021
Classification: Class III
Status: Terminated
Recall initiated: Dec 18, 2020
FDA report date: Jan 20, 2021
Quantity: 528 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: KVK-Tech, Inc.

Original FDA data

Every field from FDA enforcement report D-0224-2021, exactly as published.

Show all FDA fields

City: Newtown
State: PA
Status: Terminated
Country: United States
Event ID: 87020
Address: 110 Terry Dr
Code information: Batch# 15892A, Exp, 2021-FEB
Postal code: 18940-3427
Report date: Jan 20, 2021
Product type: Drugs
Recall number: D-0224-2021
Classification: Class III
Recalling firm: KVK-Tech, Inc.
Product quantity: 528 bottles
Termination date: Mar 19, 2021
Reason for recall: Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide
Recall initiation date: Dec 18, 2020
Initial firm notification: Letter
Center classification date: Jan 11, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0224-2021, published Jan 20, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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