Atovaquone Oral Suspension 750 mg/5 mL has been recalled after the affected product was found to have the potential for foreign particle contamination, including glass fragments. The recall affects a specific lot of the medication, not every bottle of atovaquone oral suspension.
The U.S. Food and Drug Administration (FDA) classified the recall as a Class II recall, meaning exposure to the affected product could cause temporary or medically reversible adverse health consequences, although serious harm is considered less likely.
If you or someone in your household takes atovaquone oral suspension, it is important to check the product information on the bottle before taking another dose.
What Atovaquone Oral Suspension Is
Atovaquone oral suspension is a prescription medication used to fight certain infections caused by parasites and other microorganisms.
It is commonly used for:
- Prevention of malaria in certain situations
- Treatment of Pneumocystis jirovecii pneumonia (PJP/PCP) in some patients
- Other uses determined by a healthcare professional
The medication comes as a liquid suspension, making it useful for people who may have difficulty swallowing tablets.
Because atovaquone can be prescribed for serious infections or infection prevention, people taking it should not simply stop their treatment without speaking with a healthcare professional.
Why Was Atovaquone Oral Suspension Recalled?
The recall was initiated because the affected product may contain foreign particle contamination, specifically glass fragments.
If a person takes medicine contaminated with a foreign object, there is a possibility of injury. In the case of glass particles, swallowing contaminated medication could potentially cause injury to the mouth, throat, stomach or gastrointestinal tract.
This is why the affected lot was removed from the market.
Importantly, the recall does not mean that every bottle of atovaquone oral suspension is contaminated.
The recall applies to the specific product and lot identified in the FDA recall information.
Which Atovaquone Product Is Affected?
According to the FDA recall information, the affected product is:
Product: Atovaquone Oral Suspension USP, 750 mg/5 mL
NDC: 31722-455-03
Manufacturer: American Health Packaging
Affected lot: 52486
Expiration date: October 2027
Recall initiated: August 19, 2026
FDA recall classification: Class II
If you have an atovaquone bottle at home, check the product name, strength, NDC, lot number and expiration date against the recall information.
Do not assume that your medication is affected simply because it is atovaquone.
What Does a Class II Recall Mean?
The FDA uses different classifications to describe the potential risk associated with a recalled product.
A Class II recall generally involves a product that could cause temporary or medically reversible adverse health consequences, where the likelihood of serious adverse health consequences is considered remote.
That does not mean the recalled product should be ignored.
The reason for this particular recall is especially important because the product may contain foreign material.
What Should You Do If You Have This Medication?
If you have Atovaquone Oral Suspension 750 mg/5 mL, lot 52486, do not continue using the affected product without first contacting a healthcare professional or pharmacist.
A sensible approach is:
1. Check your bottle
Look for the:
- Medication name
- Strength
- NDC number
- Lot number
- Expiration date
Compare those details with the FDA recall information.
2. Contact your pharmacist
Your pharmacist can help determine whether your bottle is part of the recall and explain how to obtain a replacement.
3. Contact your healthcare provider
This is particularly important if atovaquone was prescribed to treat an infection or prevent a serious infection.
Your doctor may need to determine whether you should switch to another medication or obtain an unaffected supply.
4. Don’t abruptly stop important treatment
One of the most important points is that a medication recall does not necessarily mean you should simply stop taking a prescribed medicine and receive no replacement.
If you are taking atovaquone for malaria prevention or treatment of PJP/PCP, speak with your healthcare provider promptly about what to do next.
5. Don’t use a recalled bottle just because it looks normal
Glass or other foreign contamination may not necessarily be obvious from casually looking at the medication.
If your bottle matches the recalled lot, follow the instructions from your pharmacist, healthcare provider, manufacturer or FDA recall notice.
What If You Already Took the Recalled Atovaquone?
If you have taken medicine from the affected lot, don’t panic.
The recall identifies a potential contamination risk; it does not mean that every dose from the lot contains a glass fragment.
However, if you experience unusual symptoms after taking the medication, seek medical advice.
Potential symptoms that deserve prompt medical attention can include:
- Severe or persistent abdominal pain
- Difficulty swallowing
- Pain in the mouth or throat
- Vomiting blood
- Blood in the stool
- Severe chest or abdominal discomfort
- Other symptoms that concern you
If you believe you may have swallowed a sharp foreign object, contact a healthcare professional promptly rather than trying to manage the situation yourself.
For severe symptoms or an emergency, seek emergency medical care.
Why Is Glass Contamination in Medicine a Concern?
Prescription medicines are expected to meet strict quality and safety standards.
A glass fragment in an oral medication can present a physical injury hazard if swallowed.
Depending on the size and location of a foreign object, it could potentially cause injury to tissues in the mouth, throat or gastrointestinal tract.
That is why pharmaceutical recalls can occur even when the probability of serious harm is considered low.
The purpose of a recall is to remove potentially affected products from circulation and reduce the possibility of patients being exposed to them.
Is All Atovaquone Recalled?
No.
This is an important distinction.
The recall concerns the identified Atovaquone Oral Suspension USP 750 mg/5 mL product and the affected lot 52486 described in the FDA recall information.
Patients should not assume that every atovaquone product, every manufacturer, or every lot is part of this recall.
Always compare the information on your own medication package with the official recall notice.
What Is Atovaquone Used For?
Atovaquone belongs to a group of medicines called antiprotozoal agents.
One important use is malaria prevention. Atovaquone is also used, often in combination with other medications depending on the situation, for the treatment of certain infections.
Another important use is treatment of Pneumocystis jirovecii pneumonia, particularly in people who cannot take certain first-line medications.
Because the medication may be used for infection treatment or prevention, getting appropriate medical guidance after a recall is important.
What Are Common Atovaquone Side Effects?
Even when the medication is not affected by the recall, atovaquone can cause side effects.
Reported side effects can include:
- Nausea
- Vomiting
- Diarrhea
- Headache
- Fever
- Rash
- Abdominal discomfort
The oral suspension should be taken exactly as prescribed.
Patients should also tell their healthcare provider about other medications and supplements they are taking because drug interactions and individual medical circumstances can affect treatment.
This information should not be used to diagnose or treat a medical condition.
What Should Parents Do?
If a child has been prescribed atovaquone oral suspension, parents and caregivers should check the bottle carefully.
Do not make an independent decision to stop an important prescribed treatment without speaking with the child’s healthcare provider or pharmacist.
If the bottle is part of the recalled lot, ask the pharmacist or prescriber about obtaining an appropriate replacement.
If a child may have swallowed a suspected glass fragment or develops concerning symptoms, seek medical attention promptly.
How to Check Your Medication
If you have atovaquone at home, take a moment to inspect the packaging.
You are looking for information such as:
Atovaquone Oral Suspension USP 750 mg/5 mL
Then check whether the:
Lot number = 52486
and whether the other identifying information corresponds with the recalled product.
Don’t rely only on the color or appearance of the liquid.
If you aren’t sure whether your bottle is affected, ask your pharmacist to check it for you.
Don’t Confuse a Medication Recall With a General Warning About the Drug
A drug recall can sound frightening, especially when people see words such as “glass” or “contamination.”
But there is an important difference between:
“This particular lot has been recalled”
and
“This medication is unsafe for everyone.”
The current recall concerns a specific product/lot. Patients taking unaffected atovaquone should not assume that their medication is part of the recall simply because it has the same drug name.
The safest approach is to verify the exact product information.
Frequently Asked Questions
Is atovaquone oral suspension being recalled?
Yes. An affected lot of Atovaquone Oral Suspension USP 750 mg/5 mL was recalled in August 2026 because of potential foreign particle contamination, including glass fragments.
What lot of atovaquone was recalled?
The affected lot identified in the FDA recall information is lot 52486.
What is the expiration date of the recalled product?
The affected product has an expiration date of October 2027.
Who manufactured the recalled atovaquone?
The recalled product was manufactured/distributed by American Health Packaging.
Is the entire atovaquone supply recalled?
No. The recall concerns the specifically identified product and lot. Check your bottle against the official FDA recall information.
Should I stop taking atovaquone?
If your medication is part of the recalled lot, contact your pharmacist or healthcare provider for instructions. If you are taking atovaquone for an important infection or infection prevention, do not simply stop treatment without obtaining medical guidance and an appropriate replacement plan.
What happens if I accidentally took the recalled medicine?
If you took medicine from the affected lot, contact your healthcare professional or pharmacist for advice. Seek urgent medical attention if you develop severe symptoms or believe you swallowed a sharp foreign object.
The Bottom Line
The Atovaquone Oral Suspension USP 750 mg/5 mL recall is related to potential foreign particle contamination, including glass fragments.
The affected product identified in the FDA recall information is:
American Health Packaging — Atovaquone Oral Suspension USP 750 mg/5 mL — NDC 31722-455-03 — Lot 52486 — Expiration October 2027.
If you have this medication, check the lot number before taking further action and contact your pharmacist or healthcare provider if it matches the recalled lot.
Most importantly, don’t ignore the recall—but don’t assume every atovaquone product is affected either. Verify the exact product and lot, and make sure you have an appropriate replacement if the medication is needed for ongoing treatment or prevention.
Sources and further reading
- U.S. Food and Drug Administration (FDA): Drug Recalls and Safety Alerts — https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
- FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/
- DailyMed: Atovaquone drug labeling and prescribing information — https://dailymed.nlm.nih.gov/dailymed/
- CDC: Malaria — https://www.cdc.gov/malaria/
Medical disclaimer: This article is for general educational purposes and is not a substitute for advice from a doctor, pharmacist, or other qualified healthcare professional. Always verify medication recalls through official FDA information and follow instructions from your healthcare provider.
