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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

AvKARE Atovaquone Oral Suspension Recalled for Potential Bacterial Contamination

Agency Publication Date: April 16, 2024
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Summary

AvKARE has voluntarily recalled 153 cartons of Atovaquone Oral Suspension USP, 750 mg per 5 mL, due to potential contamination with Bacillus cereus bacteria. This prescription medication is used to treat or prevent certain types of pneumonia and is packaged in cartons containing 20 individual 5 mL sachets. No illnesses or injuries have been reported to date in connection with this recall.

Risk

The product may be contaminated with Bacillus cereus, which can cause food poisoning symptoms such as abdominal pain, diarrhea, nausea, and vomiting. In patients with weakened immune systems, this bacterial contamination could lead to more serious or life-threatening infections.

What You Should Do

  1. This recall affects AvKARE Atovaquone Oral Suspension USP (750 mg per 5 mL) sold in cartons containing 20 individual sachets (NDC 50268-086-12).
  2. Check your packaging for lot number AW0221A with an expiration date of 08/30/2025, which can be found on both the outer carton and the individual 5 mL sachets.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atovaquone Oral Suspension USP (750 mg per 5 mL)
Variants: 750 mg/5 mL, Oral Suspension, 20 Units x 5 mL cartons
Lot Numbers:
AW0221A (Exp. 08/30/2025)
NDC:
50268-086-12
50268-086-11

Quantity: 153 cartons.

Product Images

Image 2 โ€“ Product labeling, sachet, Atovaquone Oral Suspension USP

Image 2 โ€“ Product labeling, sachet, Atovaquone Oral Suspension USP

Image 1 โ€“ Product labeling, Atovaquone Oral Suspension, USP

Image 1 โ€“ Product labeling, Atovaquone Oral Suspension, USP

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94329
Status: Resolved
Manufacturer: AvKARE
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 153 cartons
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.