Paragon 28 recalls

Par Health USA is recalling certain lots of Brevital Sodium (methohexital sodium) for injection, a 500 mg multiple-dose vial sold in the US and Canada. The vials may contain particles identified as cellulose. No injuries have been reported.

Serious·FDA·Oct 30, 2026

Par Health USA's Argatroban Injection vials contain unwanted particles—including cellulose, polystyrene, plastic, stainless steel, or rubber stopper material—in the solution. The contamination affects multiple lot numbers distributed nationwide. No injuries have been reported.

Serious·FDA·Oct 26, 20262 products

Par Health USA's Dexmedetomidine HCl injection vials contain unwanted particulate matter, identified as cellulose or stopper material. The contamination affects two specific lots distributed nationwide. This is a prescription medication used during anesthesia and sedation.

Serious·FDA·Oct 21, 2026

Par Health USA and Endo USA are recalling certain lots of Buprenorphine Hydrochloride 0.3 mg/mL injection due to crystallization in the vials. Crystallization can affect the drug's effectiveness and safety. The recall affects six specific lots distributed nationwide.

Moderate·FDA·Oct 7, 2026

Paragon 28 is recalling two custom-made navicular cage foot implants because their oxygen level is above the allowed limit. Elevated oxygen may reduce the metal's ductility, meaning it may be less able to bend before breaking. The devices were distributed across the US, and no injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

Paragon 28 received two complaints about breaches in the sterile barrier packaging of specific lots of the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (0.30 mm, 800 mm). The packaging breach could potentially allow contamination of the surgical device before use. No injuries have been reported.

Moderate·FDA·Jul 29, 2026

Par Health USA's buprenorphine HCl injection (0.3 mg/mL) has been found to contain crystallization identified as buprenorphine free base in certain lots. This affects vials distributed nationwide. The FDA has classified this as a Class II recall.

Moderate·FDA·Jun 24, 2026

Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

FDA·Dec 10, 2025