KVK-Tech, Inc. recalls Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc.,
KVK-Tech recalls 100-count benzhydrocodone/acetaminophen tablets (CII) due to impurity in stability testing. This may pose health risks if used.
Recall notice
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Contact the company & request your remedy
What happened, in plain English
KVK-Tech is recalling 100-count benzhydrocodone and acetaminophen tablets (CII) because testing found an impurity that could be harmful. This is a prescription-only product that may pose health risks if used. Read more at govinfonow.com/recall/36572-kvk-tech-recalls-benzhydrocodone-tablets-with-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36572-kvk-tech-recalls-benzhydrocodone-tablets-with-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0224-2021
Cite this page
“KVK-Tech recalls benzhydrocodone tablets with impurity risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36572-kvk-tech-recalls-benzhydrocodone-tablets-with-impurity-risk. Based on FDA recall #D-0224-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0224-2021%22&limit=1).
Why it’s dangerous
The tablets failed stability testing for a specific impurity (N-Oxide) that could be harmful. This issue was detected during long-term testing but the exact health risk isn't specified in the recall notice.
Who’s affected
Prescription patients who have the specific batch of tablets (Batch# 15892A) from KVK-Tech in Newtown, PA. Those with the product are most at risk.
How to tell if you have this one
Check for the product name 'Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/325mg, 100 Tablets, Rx Only'. Look for the batch number 15892A and expiration date of February 2021.
- Brand
KVK-Tech- Category
Drug
What to do — step by step
Check Product Details
Identify the batch number and expiration date on the product label to confirm if it matches Batch# 15892A with an expiration of February 2021.
Questions people ask
Is this product safe to use?
The recall notice states the product failed stability testing for an impurity but does not specify if it is safe to use. The manufacturer has not provided details on the health risks.
What should I do if I have this product?
The recall notice does not specify a remedy or action for affected products. You should check the product details to confirm if it matches the recalled batch.
How can I get a replacement?
The recall notice does not mention any replacement or remedy options for this product.
Contact KVK-Tech
We’ve drafted a message you can send KVK-Tech to request your refund or repair — edit it as you like.
Subject: Recall D-0224-2021 — KVK-Tech KVK-Tech Hello, I own a KVK-Tech that is covered by recall D-0224-2021 from KVK-Tech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0224-2021 (December 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0224-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.