Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx… — Class II drug recall D-0509-2021
Terminated recall by Cardinal Health Inc., reported 2021-06-02, distributed in FL, GA, SC. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
| Recall number | D-0509-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2024-06-17 |
| Distributed | FL, GA, SC |
| Quantity | 33 bottles |
| Reason classes | cgmp, temperature control |
| 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 |
Product
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Machine access
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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.