KVK-Tech Recalls Benzhydrocodone/Acetaminophen Tablets Due to Impurities
KVK-Tech recalls Batch 15892A of Benzhydrocodone and Acetaminophen Tablets due to failed impurity specifications. Check your bottle's lot number.
Use caution until it’s fixed
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
What happened, in plain English
KVK-Tech, Inc. is recalling one batch of Benzhydrocodone and Acetaminophen Tablets because they contain out-of-specification levels of an N-Oxide impurity. This issue was identified during long-term stability testing for the specific batch. The recall covers 528 bottles distributed nationwide. Read more at govinfonow.com/recall/36572-kvk-tech-recalls-benzhydrocodone-acetaminophen-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/36572-kvk-tech-recalls-benzhydrocodone-acetaminophen-tablets-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0224-2021
Cite this page
“KVK-Tech Recalls Benzhydrocodone/Acetaminophen Tablets Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36572-kvk-tech-recalls-benzhydrocodone-acetaminophen-tablets-due-to-impurities. 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 recalled tablets failed to meet specifications for N-Oxide impurity levels during stability testing. While the record does not detail specific health effects, out-of-specification impurities in prescription drugs can affect the safety and efficacy of the medication.
Who’s affected
Patients who have been prescribed Benzhydrocodone and Acetaminophen Tablets manufactured by KVK-Tech, Inc., specifically those with Batch number 15892A. Individuals possessing this specific lot are at risk of consuming a product that does not meet purity standards.
How to tell if you have this one
Check your medication bottle for the following details: Brand/Manufacturer: KVK-Tech, Inc.; Product: Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/325mg; NDC: 10702-344-01; Batch Number: 15892A; Expiration Date: 2021-FEB.
- Brand
KVK-Tech- Category
Drug
What to do — step by step
Check Your Lot Number
Verify if your bottle matches Batch number 15892A and NDC 10702-344-01.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the appropriate next steps for your prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
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 qwen3.6:35b-a3b on October 11, 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.