FDA Drug recall D-0632-2022
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsbo…
- FDA Drug
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsbo… by Macleods Pharma Usa, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0632-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-15 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
Product
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.
Reason
cGMP deviations
Identifiers
| ndc | 33342-190-07 |
|---|---|
| ndc | 33342-190-10 |
| ndc | 33342-190-12 |
| ndc | 33342-190-44 |
| ndc | 33342-191-07 |
| ndc | 33342-191-10 |
| ndc | 33342-191-12 |
| ndc | 33342-191-44 |
| ndc | 33342-192-07 |
| ndc | 33342-192-10 |
| ndc | 33342-192-12 |
| ndc | 33342-192-44 |
| ndc | 33342-193-07 |
| ndc | 33342-193-10 |
| ndc | 33342-193-12 |
| ndc | 33342-193-44 |
| code_info | Lot#: BAD62101A, Exp 2/2024 |
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-0632-2022%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.