Amlodipine and Olmesartan Medoxomil Tablets — Class III drug recall D-0289-2019
Terminated recall by Aurobindo Pharma USA Inc., reported 2018-12-12, distributed nationwide. Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot
| Recall number | D-0289-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2018-11-30 |
| Classified | 2018-12-06 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2022-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 4,464 bottles |
| NDC | 65862-0854, 65862-0854-30, 65862-0855, 65862-0855-30, 65862-0856, 65862-0856-30, 65862-0857, 65862-0857-30 |
| Lot numbers | OWSA18002-A |
| Expiration dates | 2020-07 |
Product
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Reason for recall
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
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-0289-2019. 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.