CLASS III Drug recall · Reported 3 Jan 2018 · FDA Enforcement Report
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored recalled
Bayer HealthCare Pharmaceuticals is recalling Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored. The recall was initiated on 10 Nov 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0135-2018
- FDA event ID
- 78505
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Whippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Nov 2017
- FDA classified
- 28 Dec 2017
- Reported
- 3 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 10 Nov 2017 | Recall initiated by company | |
| 28 Dec 2017 | Classified by FDA | +48 days |
| 3 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Natonwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot # NAA3T0X; Exp. 07/18
Where was it sold?
Natonwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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