FDA Drug recall D-0049-2021
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-cou…
- FDA Drug
- Class III
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class III recall of Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-cou… by Mylan Pharmaceuticals, citing out-of-specification organic impurity results obtained during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0049-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-10-02 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason
Out-of-specification organic impurity results obtained during routine stability testing.
Identifiers
| ndc | 0378-3001-77 |
|---|---|
| ndc | 0378-3002-77 |
| ndc | 0378-3003-77 |
| ndc | 0378-3002-05 |
| code_info | Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Mylan Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0049-2021%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.