CLASS II Drug recall · Reported 25 Mar 2020 · FDA Enforcement Report
Sotalol HCL Tablets, USP (AF) 80 mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Sotalol HCL Tablets, USP (AF) 80 mg, distributed nationwide in the US. The recall was initiated on 9 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1031-2020
- FDA event ID
- 85152
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2020
- FDA classified
- 18 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 9 Mar 2020 | Recall initiated by company | |
| 18 Mar 2020 | Classified by FDA | +9 days |
| 25 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter. presence of metal particles.
Product as listed by the FDA
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of particulate matter. presence of metal particles.
Which lots are affected?
Lot # 3095754, exp. date 02/2021
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sotalol recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sotalol HCL, Tablet, 120 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Sotalol HCL, Tablet, 160 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Sotalol HCL, Tablet, 80 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |