Par Health Initiates Voluntary Recall of Brevital Sodium Injection Due to Safety Concerns
On October 8, 2026, Par Health announced a significant voluntary recall for two specific lots of Brevital® Sodium (Methohexital Sodium for Injection, USP) due to the discovery of particulate matter in the product. This sodium formulation, primarily used for intravenous anesthesia and sedation, has become a matter of urgent medical concern.
The recalled lots of Brevital Sodium include Lot 86930, with an expiration date of February 2028, and Lot 88623, expiring in April 2028. This recall affects products distributed nationwide to wholesalers between July 8, 2025, and May 11, 2026. Medical professionals using this anesthetic should take immediate action, ceasing usage and distribution of these lots.
The presence of cellulose, identified as particulate matter, carries with it serious health risks. Administration of contaminated Brevital Sodium could potentially lead to life-threatening conditions, such as pulmonary embolisms, where blood vessels in the lungs become obstructed, and occlusions of other blood vessels that could lead to tissue death or organ damage. Furthermore, inflammation in veins may lead to clotting complications.
So far, Par Health has not reported any adverse events linked to this recall, but necessary precautions are being taken. The company is actively notifying wholesale accounts and coordinating the return of the problematic inventory through Inmar, Inc. Healthcare facilities that have received this product must inform their accounts and halt any further distribution immediately.
Identifying the recalled Brevital Sodium product is crucial. The product comes in vials marked as follows:
For additional assistance regarding the recall, healthcare professionals can reach out to Inmar, Inc. via phone at 1-844-774-1187. Medical inquiries or reports about adverse events can be directed to Par Health’s hotline by calling 1-800-828-9393 during designated hours.
Healthcare professionals and patients are encouraged to report any adverse reactions or quality concerns associated with this product under the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, via mail, or fax, reinforcing the importance of monitoring the safety and efficacy of pharmaceuticals actively.
This recall underscores the critical nature of quality control in medical supplies and the continued commitment of Par Health to patient safety. As part of a proactive strategy, the company recognizes its responsibility to minimize risks associated with product usage. Further communications and updates will be provided timely to ensure that all stakeholders are informed, protecting both patients and healthcare professionals across the country.
Details of the Recall
The recalled lots of Brevital Sodium include Lot 86930, with an expiration date of February 2028, and Lot 88623, expiring in April 2028. This recall affects products distributed nationwide to wholesalers between July 8, 2025, and May 11, 2026. Medical professionals using this anesthetic should take immediate action, ceasing usage and distribution of these lots.
Health Risks
The presence of cellulose, identified as particulate matter, carries with it serious health risks. Administration of contaminated Brevital Sodium could potentially lead to life-threatening conditions, such as pulmonary embolisms, where blood vessels in the lungs become obstructed, and occlusions of other blood vessels that could lead to tissue death or organ damage. Furthermore, inflammation in veins may lead to clotting complications.
Company's Response
So far, Par Health has not reported any adverse events linked to this recall, but necessary precautions are being taken. The company is actively notifying wholesale accounts and coordinating the return of the problematic inventory through Inmar, Inc. Healthcare facilities that have received this product must inform their accounts and halt any further distribution immediately.
Product Identification
Identifying the recalled Brevital Sodium product is crucial. The product comes in vials marked as follows:
- - NDC: 42023-105-01
- - Lot: 86930 (Expiration: 02/2028)
- - Lot: 88623 (Expiration: 04/2028)
For additional assistance regarding the recall, healthcare professionals can reach out to Inmar, Inc. via phone at 1-844-774-1187. Medical inquiries or reports about adverse events can be directed to Par Health’s hotline by calling 1-800-828-9393 during designated hours.
Reporting Adverse Events
Healthcare professionals and patients are encouraged to report any adverse reactions or quality concerns associated with this product under the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, via mail, or fax, reinforcing the importance of monitoring the safety and efficacy of pharmaceuticals actively.
This recall underscores the critical nature of quality control in medical supplies and the continued commitment of Par Health to patient safety. As part of a proactive strategy, the company recognizes its responsibility to minimize risks associated with product usage. Further communications and updates will be provided timely to ensure that all stakeholders are informed, protecting both patients and healthcare professionals across the country.
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