Class II · Moderate risk
Aspirin Chewable tablet 81 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What 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
Affected NDC
0280-2160-36
Compare with the code on your package — it is the most precise check available.
Drug: Aspirin Category: Pain Relief & OTC Medication
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Inc.
- NDC code
- 0280-2160-36
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0135-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Aspirin recalls
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Class I · High risk
Healthy Living Acetaminophen
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class II · Moderate risk
Fw Aspirin Chewable Tablet 36ct Sku 913990 Gs Enteric Aspirin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
HPC Tablet
CGMP Deviations
Other recalls by Bayer HealthCare Pharmaceuticals, Inc.
All 2017 recalls
Class I · High risk
VITRAKVI (larotractenib)
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
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