Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets — Class III drug recall D-0135-2018
Terminated recall by Bayer HealthCare Pharmaceuticals, Inc., reported 2018-01-03. Failed Stability Specifications
| Recall number | D-0135-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, United States |
| Recall initiated | 2017-11-10 |
| Classified | 2017-12-28 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2020-04-03 |
| Quantity | 104,128 hdpe |
| Reason classes | specification failure |
| NDC | 00280-2160-36 |
| Lot numbers | 07/18, NAA3T0X |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0135-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.