On September 1, 2021, the U.S. Food and Drug Administration (FDA) announced that KVK-Tech is voluntarily recalling two lots of Atovaquone Oral Suspension 750mg/5mL as a Class I Recall.

Only two lots are being recalled due to unusual grittiness in the product. This was most likely caused by prolonged exposure of these lots to extremely cold weather during shipment.

Please note that not all lots are affected, so you may not be affected by this recall. If you are currently taking Atovaquone Oral Suspension 750mg/5mL, please contact your health care provider to discuss which other treatments or medicines may be appropriate.

For more information, please visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kvk-tech-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5ml-due. You can also contact KVK-Tech by phone at 1-215-579-1842 x6002 (TTY 711), weekdays, 8 a.m. to 4:30 p.m., Eastern Time (ET), or email at recall@kvktech.com. You can also call the Horizon NJ Health Pharmacy Help Desk at 1-800-682-9094 x81016 (TTY 711), Monday through Friday, 8 a.m. to 6 p.m., and Saturday 8 a.m. to 4:30 p.m., ET.