CLASS I Drug recall · Reported 1 Sep 2021 · FDA Enforcement Report
Atovaquone Oral Suspension, USP, 750 mg recalled by KVK-Tech
KVK-Tech is recalling Atovaquone Oral Suspension, USP, 750 mg, distributed nationwide in the US. The recall was initiated on 2 Jul 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0772-2021
- FDA event ID
- 88220
- Recalling firm
- KVK-Tech, Newtown, PA
- Manufacturer
- KVK-Tech, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Jul 2021
- FDA classified
- 26 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
Timeline
| 2 Jul 2021 | Recall initiated by company | |
| 26 Aug 2021 | Classified by FDA | +55 days |
| 1 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
Where it was distributed
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Questions about this recall
Is Atovaquone Oral Suspension, USP, 750 mg recalled?
Yes. KVK-Tech recalled Atovaquone Oral Suspension, USP, 750 mg on 2 Jul 2021. The recall is Class I and its status is Terminated. Recall number D-0772-2021.
Why was it recalled?
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Which lots are affected?
Batch # 16653A, 16654A, Exp 12/2022
Where was it sold?
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from KVK-Tech
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|---|---|---|---|---|---|
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 30mg recalled by KVK TechPhentermine Hydrochloride | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS I | Betaxolol Tablets, USP 10 mg recalled by KVK-TechBetaxolol Hydrochloride | KVK-Tech | Other | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | KVK-Tech | Potency & Assay | Nationwide |
| Drug | CLASS III | Benzhydrocodone and Acetaminophen Tablets, CII, 12mg/ 325mg recalled | KVK-Tech | Potency & Assay | Nationwide |
Other Atovaquone recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atovaquone Oral Suspension, USP 750 mg recalled by BionpharmaAtovaquone | Bionpharma | Sterility | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension USP, 750 mg per sachets x recalled by AvKARE | AvKARE | Sterility | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension USP, 750 mg recalledAtovaquone | Camber Pharmaceuticals | Sterility | Nationwide |