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FDA Class II Recall for BZK PADS

The FDA has initiated a Class II recall for BZK PADS (Benzalkonium Chloride) manufactured by Dynarex Corporation, distributed by ACME UNITED CORPORATION. The recall is due to CGMP deviations and is ongoing nationwide.

Urgent Enforcement Pharmaceuticals
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FDA Class II Recall of Midodrine Hydrochloride Tablets

The FDA has announced an ongoing Class II recall for Midodrine Hydrochloride Tablets, USP, 5 mg, initiated by The Harvard Drug Group LLC due to inadequately sealed blister packaging. The recall affects approximately 8,892 cartons distributed nationwide.

Urgent Enforcement Pharmaceuticals
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FDA Class II Drug Recall - Semaglutide

The FDA has announced a Class II drug recall initiated voluntarily by Harbin Jixianglong Biotech Co., Ltd. of China for Semaglutide intended for compounding use. The recall is due to CGMP deviations, specifically failing to complete process validation and bacterial endotoxin method validation before distribution.

Urgent Enforcement Pharmaceuticals
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iRobot Corporation - Chapter 11 Bankruptcy Filing and Reorganization Plan Confirmation

iRobot Corporation and its subsidiaries have filed a Form 8-K to report the confirmation of their prepackaged Chapter 11 plan of reorganization by the U.S. Bankruptcy Court for the District of Delaware. The plan, which effectuates a financial restructuring, was voted on by Shenzhen PICEA Robotics Co., Ltd. and its subsidiary Santrum Hong Kong Co., Limited, as per a restructuring support agreement.

Urgent Enforcement Bankruptcy
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Nine Energy Service, Inc. Files Chapter 11 Bankruptcy

Nine Energy Service, Inc. and certain subsidiaries filed voluntary Chapter 11 bankruptcy petitions on February 1, 2026, to implement a prepackaged plan of reorganization. The company continues to operate as debtors-in-possession.

Urgent Enforcement Bankruptcy
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Zynex Inc. Files Form 8-K Regarding Bankruptcy Proceedings

Zynex, Inc. filed a Form 8-K on January 14, 2026, reporting its voluntary Chapter 11 bankruptcy filings initiated on December 15, 2025. The filing also details Nasdaq's determination to delist the company's common stock due to the bankruptcy proceedings.

Urgent Enforcement Bankruptcy
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Office Properties Income Trust - Bankruptcy Filing and DIP Financing

Office Properties Income Trust (OPI) filed a Form 8-K reporting on the entry into an Amended and Restated Debtor-in-Possession Credit Agreement on February 4, 2026. This follows their Chapter 11 bankruptcy filing on October 30, 2025, to implement a financial restructuring.

Urgent Enforcement Banking
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Dynatronics Corp. Files Chapter 7 Bankruptcy

Dynatronics Corp. and its subsidiaries have filed for Chapter 7 bankruptcy relief in the U.S. Bankruptcy Court for the District of Minnesota. This action involves the cessation of all operations and the liquidation of assets by a court-appointed trustee. The bankruptcy filings have triggered default events under certain company contracts, including a loan agreement with Gibraltar Business Capital, LLC.

Urgent Enforcement Bankruptcy
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Western Alliance Bancorporation - Material Impairment Disclosure

Western Alliance Bancorporation disclosed a material impairment of $126.4 million due to a counterparty default on a commercial loan facility. The company has recognized a non-cash impairment charge for the first quarter of 2026 and is pursuing legal action to recover the outstanding balance.

Priority review Enforcement Financial Services
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Molina Healthcare - Amendment to Credit Agreement

Molina Healthcare, Inc. filed an 8-K report detailing an amendment to its Credit Agreement, effective February 4, 2026. The amendment temporarily reduces the quarterly required minimum interest coverage ratio from 3.00:1.00 to a lower tiered ratio through September 30, 2027.

Priority review Notice Financial Services

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