KVK-Tech Recalls Hydrocodone Oral Solution Due to Foreign Particles
KVK-Tech recalls specific lots of Hydrocodone Bitartrate and Homatropine Methylobromide Oral Solution due to black particles found in the liquid.
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Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
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What happened, in plain English
KVK-Tech, Inc. is recalling Hydrocodone Bitartrate and Homatropine Methylobromide Oral Solution because black particles were discovered in the product during a retain sample inspection. The recall affects 1,534 bottles distributed nationwide. Consumers should check their medication against the specific lot numbers listed below. Read more at govinfonow.com/recall/37773-kvk-tech-recalls-hydrocodone-oral-solution-due-to-foreign-particles.
Source Summary by GovInfoNow · govinfonow.com/recall/37773-kvk-tech-recalls-hydrocodone-oral-solution-due-to-foreign-particles · Updated October 11, 2026 · FDA enforcement record: FDA #D-0532-2020
Cite this page
“KVK-Tech Recalls Hydrocodone Oral Solution Due to Foreign Particles.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37773-kvk-tech-recalls-hydrocodone-oral-solution-due-to-foreign-particles. 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 presence of black particles in the oral solution poses a contamination risk. Ingesting these foreign substances could lead to adverse health effects, although specific injuries are not detailed in the record.
Who’s affected
Patients currently taking this prescription oral solution for pain or cough management. Individuals who have purchased the affected lots between manufacture and the recall date are at risk of ingesting foreign substances.
How to tell if you have this one
Check your bottle for the NDC 10702-150-16 and look for black particles inside the liquid. The recalled bottles are 473 mL size, manufactured by KVK-Tech, Inc. in Newtown, PA. Affected lots are 14375A (Exp. date 2019-DEC) and 14398A (Exp. date 2020-JAN).
- Brand
KVK-Tech- Category
Drug
What to do — step by step
Stop using the medication
Do not consume the oral solution if it contains black particles or matches the recalled lot numbers.
Contact your pharmacist
Reach out to your pharmacy or healthcare provider for instructions on returning the product and obtaining a replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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 qwen3.6:35b-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.