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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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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Aero Tab Acetaminophen Caffeine Recalled for Ingredient Label Mix-up

Agency Publication Date: November 5, 2025
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Summary

Aero Healthcare is recalling its Aero Tab Acetaminophen (500mg) and Caffeine (65mg) caplets because the outer box contains incorrect ingredient information. While the outer box lists acetaminophen and a higher dose of caffeine, the individual pouches inside actually contain Aspirin (500mg) and a lower dose of Caffeine (32.5mg). This labeling error could lead consumers to accidentally ingest aspirin, which poses serious health risks for certain individuals, including those with aspirin allergies or those at risk of Reye's syndrome.

Risk

Consumers expecting acetaminophen may unknowingly ingest aspirin, which can cause severe allergic reactions in sensitive individuals or increase the risk of internal bleeding. In children and teenagers, the accidental use of aspirin while recovering from viral infections can lead to Reye's syndrome, a rare but life-threatening condition.

What You Should Do

  1. Check your medicine supply for Aero Tab Acetaminophen 500mg Caffeine 65mg caplets in 50-count boxes (NDC 55305-135-01).
  2. Look for lot numbers 9282 (Expiration: 2026-09-01) or 9310 (Expiration: 2026-11-01) printed on the packaging.
  3. If you have health concerns or believe you have had an adverse reaction after taking this medication, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Aero Healthcare for further instructions.
  5. 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: Acetaminophen 500mg Caffeine 65mg caplets (AERO TAB)
Variants: 2 caplets per packet, 50-count box
Lot Numbers:
9282 (Exp 2026-09-01)
9310 (Exp 2026-11-01)
NDC:
55305-135-01

The outer box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg, but the inner pouch correctly identifies the ingredients as Aspirin 500mg and Caffeine 32.5mg.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97809
Status: Active
Manufacturer: Aero Healthcare
Manufactured In: United States
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 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.