Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported January 3, 2018
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
Failed Stability Specifications
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Bayer HealthCare Pharmaceuticals, Inc. recalled Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distribu… - a low-severity action.
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distribu… was recalled by Bayer HealthCare Pharmaceuticals, Inc. in January 3, 2018. Reason: Failed Stability Specifications. Check the official notice for the remedy. Verify recall #D-0135-2018 with the FDA Drug before acting.
The recall
Bayer HealthCare Pharmaceuticals, Inc. issued this low-severity FDA Drug recall-Failed Stability Specifications.
- Low
- severity level
- Class III
- classification
- January 3, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0135-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0135-2018) was formally reported on January 3, 2018, with the manufacturer initiating the action on November 10, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Bayer HealthCare Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Whippany, NJ. Federal records list the affected scope as 104,128 HDPE bottles.
The documented reason for this recall is: Failed Stability Specifications Distribution data in the federal record shows the product reached: Natonwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
104,128 HDPE bottles
Related Recalls
6
5 from same agency
Product description
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
Reason for recall
Failed Stability Specifications
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0135-2018 |
| Date reported | January 3, 2018 |
| Date initiated | November 10, 2017 |
| Recalling firm | Bayer HealthCare Pharmaceuticals, Inc. |
| Firm location | Whippany, NJ |
| Affected scope | 104,128 HDPE bottles |
| Distribution | Natonwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0135-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577. Recalled by Bayer HealthCare Pharmaceuticals, Inc.. Units affected: 104,128 HDPE bottles.
Why was this product recalled? ▼
Failed Stability Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2018. Severity: Low. Recall number: D-0135-2018.
Where was the recalled product distributed? ▼
Distribution: Natonwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0135-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 3, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.