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Drug recall · FDA · Published November 1, 2019

KVK-Tech, Inc. recalls Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd.

KVK-Tech recalls 473mL hydrocodone/homatropine oral solutions with black particles. Rx-only bottles from lots 14375A (exp 2019) and 14398A (exp 2020) may contain foreign material.

🇺🇸 FDA recall #D-0532-2020DrugKVK-Tech ›
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Contact the company & request your remedy

Recalling firmKVK-Tech, Inc.110 Terry Dr, N/A · Newtown, PA 18940-3427
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

KVK-Tech is recalling hydrocodone and homatropine oral solutions that may contain black particles. This could pose a risk if the particles are ingested, though the recall doesn't specify how serious the risk is. Read more at govinfonow.com/recall/37773-kvk-tech-hydrocodone-oral-solution-recall-black-particles-found.

Source Summary by GovInfoNow · govinfonow.com/recall/37773-kvk-tech-hydrocodone-oral-solution-recall-black-particles-found · Updated October 5, 2026 · FDA enforcement record: FDA #D-0532-2020

Cite this page

“KVK-Tech Hydrocodone Oral Solution Recall: Black Particles Found.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37773-kvk-tech-hydrocodone-oral-solution-recall-black-particles-found. Based on FDA recall #D-0532-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0532-2020%22&limit=1).

Why it’s dangerous

The recall states black particles were found in the samples during testing. These particles could be harmful if ingested, but the record doesn't explain how serious the risk is or if the particles cause injury.

Who’s affected

Prescription users of the 473mL hydrocodone/homatropine oral solution bottles with specific lot numbers. People who have the product and are taking it for pain or other medical conditions.

How to tell if you have this one

Check for bottles labeled 'Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL' with lot numbers 14375A (expires Dec 2019) or 14398A (expires Jan 2020).

  • Brand
    KVK-Tech
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the specific lot numbers 14375A or 14398A on the bottle label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states black particles were found but doesn't specify if the product is safe to use. The manufacturer recommends checking the lot numbers and following the action steps.

What should I do if I have this product?

The recall doesn't provide a remedy, so you should check the lot numbers and contact the manufacturer if you have the specific lot numbers mentioned.

How can I tell if I have the recalled product?

Check for bottles labeled 'Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL' with lot numbers 14375A (expires Dec 2019) or 14398A (expires Jan 2020).

Take action

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-0532-2020 — KVK-Tech KVK-Tech

Hello,

I own a KVK-Tech that is covered by recall D-0532-2020 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-0532-2020 (November 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0532-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA