FDA Drug recall D-0412-2021
Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmac…
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmac… by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0412-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
Product
Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 62332-115-30 |
|---|---|
| ndc | 62332-115-31 |
| ndc | 62332-115-91 |
| ndc | 62332-116-30 |
| ndc | 62332-116-31 |
| ndc | 62332-116-71 |
| ndc | 62332-117-30 |
| ndc | 62332-117-31 |
| ndc | 62332-117-71 |
| ndc | 2005005745 |
| code_info | 2005005745 |
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-0412-2021%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.