Bayer Chewable Aspirin Recall: Failed Stability Specifications
Bayer is recalling orange-flavored 81mg chewable aspirin tablets made in Spain due to failed stability specifications. This may affect product safety and effectiveness.
Lower-risk recall
Failed Stability Specifications
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What happened, in plain English
Bayer is recalling orange-flavored 81mg chewable aspirin tablets made in Spain because they failed stability tests. This could mean the medication might not work as intended or could be unsafe. Read more at govinfonow.com/recall/41099-bayer-chewable-aspirin-recall-failed-stability-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41099-bayer-chewable-aspirin-recall-failed-stability-specifications · Updated October 7, 2026 · FDA enforcement record: FDA #D-0135-2018
Cite this page
“Bayer Chewable Aspirin Recall: Failed Stability Specifications.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41099-bayer-chewable-aspirin-recall-failed-stability-specifications. Based on FDA recall #D-0135-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0135-2018%22&limit=1).
Why it’s dangerous
The product failed stability specifications, meaning it may not be effective or could be unsafe. This could happen if the medication degrades over time, especially after the expiration date.
Who’s affected
People who own or use the recalled Bayer Chewable Low Dose Aspirin 8:1 mg Orange Flavored 36 tablets made in Spain are affected. Those who take the product regularly are most at risk.
How to tell if you have this one
Check for the orange-flavored 81mg chewable aspirin tablets with NDC 0280-2160-36 and UPC 3128431310577. The lot number is NAA3T0X and it expires July 2018.
- Brand
Bayer- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0280-2160-36 and UPC 3128431310577 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0135-2018 (November 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0135-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.