FDA Drug recall D-0289-2019
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton…
- FDA Drug
- Class III
- terminated
- Published 2018-12-12
On 2018-12-12 the FDA classified a Class III recall of Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton… by Aurobindo Pharma Usa, citing 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).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0289-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-30 |
| Published | 2018-12-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
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).
Identifiers
| ndc | 65862-854-30 |
|---|---|
| ndc | 65862-855-30 |
| ndc | 65862-856-30 |
| ndc | 65862-857-30 |
| code_info | Lot#: OWSA18002-A, Exp 7/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.