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Lower risk Drug recall · FDA · Published July 2, 2021

KVK-Tech Atovaquone Oral Suspension Recall: Unusual Grittiness Complaints

KVK-Tech recalls Atovaquone Oral Suspension (750 mg/5 mL, 210 mL) due to customer reports of unusual grittiness. This medication is prescription-only and may be affected by specific batch numbers.

🇺🇸 FDA recall #D-0772-2021DrugKVK-Tech ›
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Recalling firmKVK-Tech, Inc.110 Terry Dr · Newtown, PA 18940-3427
✎ GovInfoNow plain-language explainer

KVK-Tech is recalling a prescription atovaquone oral suspension product because customers reported unusual grittiness. This issue could affect the medication's safety and effectiveness if the grittiness causes problems when taken. Read more at govinfonow.com/recall/36101-kvk-tech-atovaquone-oral-suspension-recall-unusual-grittiness-complaints.

Source Summary by GovInfoNow · govinfonow.com/recall/36101-kvk-tech-atovaquone-oral-suspension-recall-unusual-grittiness-complaints · Updated August 18, 2026 · FDA enforcement record: FDA #D-0772-2021

Cite this page

“KVK-Tech Atovaquone Oral Suspension Recall: Unusual Grittiness Complaints.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36101-kvk-tech-atovaquone-oral-suspension-recall-unusual-grittiness-complaints. Based on FDA recall #D-0772-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0772-2021%22&limit=1).

KVK-Tech, Inc. recalled Atovaquone Oral Suspension, USP due to temperature abuse that may cause grittiness, the FDA announced on July 2, 2021. The firm initiated this voluntary Class I recall after receiving customer complaints regarding the product's texture.

How to tell if you have it

  • Brand: KVK-Tech
  • Product: Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle
  • NDC: 10702-223-21
  • Batch numbers: 16653A, 16654A
  • Expiration date: 12/2022

The hazard

The recall addresses temperature abuse of the oral suspension. The firm received customer complaints reporting unusual grittiness in the product.

Context

GovInfoNow's records show KVK Tech, Inc. has had 11 other recalls on record since December 11, 2013. Recent brand recalls include Phentermine Capsules recalled on May 9, 2025, due to manufacturing deviations, and Betaxolol Tablets recalled on September 20, 2023, for the risk of oxycodone contamination. Other recent recalls of similar products include Taro's Children's Ibuprofen recall on March 2, 2026, due to a foreign substance, and Guardian Drug Goodsense Ultra Strength Antacid Tablets recalled on May 28, 2026, for metallic particles.

How to tell if you have this one

Check for the product name 'Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle' with the NDC 10702-223-21. The affected batches are 16653A and 16654A, expiring December 2022.

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

What to do — step by step

  1. Check Product Details

    Verify the product name, NDC number, and batch numbers to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Product was distributed to one distributor who may have further distributed Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Jul 2, 202112. FDA classified it Class I: Aug 26, 202123. Published in FDA’s Enforcement Report: Sep 1, 202134. FDA terminated the recall: May 23, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. 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-0772-2021 (July 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0772-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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