Amlodipine and Olmesartan Medoxomil Tablets — Class II drug recall D-0632-2022
Terminated recall by Macleods Pharma Usa Inc, reported 2022-03-09, distributed nationwide. cGMP deviations
| Recall number | D-0632-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2022-02-15 |
| Classified | 2022-02-25 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2023-02-17 |
| Distributed | Nationwide (US) |
| Quantity | 3,672 bottles |
| Reason classes | cgmp |
| NDC | 33342-0190, 33342-0190-07, 33342-0190-10, 33342-0190-12, 33342-0190-44, 33342-0191, 33342-0191-07, 33342-0191-10, 33342-0191-12, 33342-0191-44, 33342-0192, 33342-0192-07, 33342-0192-10, 33342-0192-12, 33342-0192-44, 33342-0193, 33342-0193-07, 33342-0193-10, 33342-0193-12, 33342-0193-44 |
| Lot numbers | BAD62101A |
| Expiration dates | 2024-02 |
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 for recall
cGMP deviations
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-0632-2022. 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.