FDA Drug recall D-0798-2021
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-323…
- FDA Drug
- Class III
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class III recall of Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-323… by Viatris, citing failed Impurities/Degradation Specifications; out of specification for Related Compound.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0798-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-09-13 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
Product
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Reason
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Identifiers
| ndc | 0378-3224-93 |
|---|---|
| ndc | 0378-3224-77 |
| ndc | 0378-3225-93 |
| ndc | 0378-3225-77 |
| ndc | 0378-3231-93 |
| ndc | 0378-3231-77 |
| ndc | 0378-3232-93 |
| ndc | 0378-3232-77 |
| code_info | Lot # 3107334, exp. date October 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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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0798-2021%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.