FDA Drug recall D-1031-2020
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc
- FDA Drug
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc by Mylan Pharmaceuticals, citing presence of particulate matter. presence of metal particles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1031-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-09 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Reason
Presence of particulate matter. presence of metal particles.
Identifiers
| code_info | Lot # 3095754, exp. date 02/2021 |
|---|
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-1031-2020%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.