Atovaquone Oral Suspension Recalled for Temperature Abuse
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which per the rubric requires a minimum severity score of 4. Temperature-induced physical changes to a prescription drug can compromise therapeutic efficacy and safety, warranting a Severe rating.
Plain-English summary
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL, 210 mL bottles) due to temperature abuse during storage or distribution. The firm received customer complaints reporting unusual grittiness in the product.
Batch numbers 16653A and 16654A with expiration dates of 12/2022 are affected. The product was distributed to one distributor who may have further distributed it nationwide in the USA.
Consumers and healthcare providers in possession of this medication should not use it. Patients taking Atovaquone should contact their healthcare provider for guidance on obtaining a replacement or alternative medication. The FDA classifies this as a Class I recall.
The recalled product
- Product
- ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
- Brand
- ATOVAQUONE ORAL SUSPENSION
- Manufacturer
- KVK-Tech, Inc.
- Affected units
- 1,692
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch # 16653A
- 16654A
- Exp 12/2022
UPCs (1)
- 0310702223219
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · KVK-Tech, Inc.
See all →- ModeratePhentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateIndomethacin Extended-Release Capsules Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-28
- SevereBetaxolol Hydrochloride tablets recalled due to oxycodone contamination
FDA (Drugs) · 2023-10-25
- ModerateKVK-Tech Recalls Hydrocodone and Homatropine Tablets for Impurity Failures
FDA (Drugs) · 2021-05-26
- LowKVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity
FDA (Drugs) · 2021-01-20
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- SevereAtovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination
FDA (Drugs) · 2024-10-23
- LowKVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity
FDA (Drugs) · 2021-01-20
- SevereAtovaquone Oral Suspension Recalled for Bacillus cereus Contamination
FDA (Drugs) · 2023-05-17
- ModerateCiprofloxacin and dexamethasone otic suspension recalled following temperature abuse
FDA (Drugs) · 2025-09-17
- LowHi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures
FDA (Drugs) · 2014-01-01
- ModerateKVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles
FDA (Drugs) · 2019-11-20