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

Bayer HealthCare Pharmaceuticals, Inc.: Chewable Low Dose Aspirin Recalled for Failed Stability Specifications

Agency Publication Date: December 28, 2017
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Summary

Bayer HealthCare Pharmaceuticals is recalling approximately 104,128 bottles of Bayer Chewable Low Dose Aspirin 81 mg (orange flavored). The recall was initiated because the product failed stability specifications, meaning the medication may not maintain its expected effectiveness or quality through the end of its labeled shelf life. This recall affects 36-count HDPE bottles distributed nationwide. Consumers should consult with a healthcare professional regarding any concerns about the effectiveness of their medication.

Risk

The product failed stability testing, which can lead to the medication losing its potency or chemical integrity before the expiration date. While this is considered a low-risk situation, the medication may not provide the full therapeutic benefit intended for the user.

What You Should Do

  1. Check your bottle of Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored (36 tablets) for Lot number NAA3T0X and an expiration date of 07/18.
  2. Verify the UPC code 3128431310577 and NDC 0280-2160-36 on the product packaging to confirm if your bottle is part of this recall.
  3. If your product matches the affected lot, contact your healthcare provider or pharmacist for guidance regarding your treatment and the effectiveness of the medication.
  4. Return any unused portion of the recalled product to the pharmacy or place of purchase for a refund.
  5. Contact Bayer HealthCare Pharmaceuticals for further instructions or to report any concerns regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund or guidance for affected medication

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored (36 tablets)
Model:
NDC 0280-2160-36
Recall #: D-0135-2018
UPC Codes:
3128431310577
Lot Numbers:
NAA3T0X (Exp. 07/18)
Date Ranges: Expiration 07/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78505
Status: Resolved
Manufacturer: Bayer HealthCare Pharmaceuticals, Inc.
Sold By: pharmacies; retailers
Manufactured In: Spain, United States
Units Affected: 104,128 HDPE bottles
Distributed To: Nationwide

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.