Sotalol HCL Tablets — Class II drug recall D-1031-2020
Terminated recall by Mylan Pharmaceuticals Inc., reported 2020-03-25, distributed nationwide. Presence of particulate matter. presence of metal particles.
| Recall number | D-1031-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2020-03-09 |
| Classified | 2020-03-18 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-05-26 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00378-5123-01 |
| Lot numbers | 3095754 |
| Expiration dates | 2021-02 |
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 for recall
Presence of particulate matter. presence of metal particles.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1031-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.