Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Mar 9, 2020 (7 years ago)

Sotalol HCL Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of particulate matter. presence of metal particles.

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

Affected NDC 0378-5123-01

Compare with the code on your package — it is the most precise check available.

Drug: Sotalol

Recalling firm
Mylan Pharmaceuticals Inc.
NDC code
00378-5123-01
Origin
WV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1031-2020 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Sotalol recalls

See all
Class II · Moderate risk

Sotalol HCL

Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the following drug: DISULFIRAM, Tablet, 250 mg, NDC 64980017101, Pedigree: AD22609_1, EXP: 5/2/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-834-2014
Class II · Moderate risk

Sotalol HCL

Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014; PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-833-2014
Class II · Moderate risk

Sotalol HCL

Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the following drug: NEOMYCIN SULFATE, Tablet, 500 mg, NDC 51991073801, Pedigree: AD49448_17, EXP: 5/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-832-2014

Other recalls by Mylan Pharmaceuticals Inc.

All 2020 recalls
Class II · Moderate risk

Prasugrel Tablets

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Ongoing Dissolution failure Mylan Pharmaceuticals Inc NDC 0378-5186-93 D-0839-2026