Drug and pharmaceutical recalls

Baxter Healthcare is recalling specific lots of MYXREDLIN (insulin human injection) due to deviations from current Good Manufacturing Practice (CGMP) standards during production. The affected lots were distributed in the US, Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare Corporation is recalling five lots of Vancomycin Injection USP in 5% Dextrose due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The affected lots were distributed nationwide, in Puerto Rico, and Chile.

Golden State Medical Supply Inc. is recalling Prasugrel HCI 10mg tablets (lot GS062298, expiration 09/30/2026) because they failed to meet dissolution specifications during quality testing. Dissolution is how quickly a tablet breaks down in the body to release its active ingredient. Tablets that dissolve too slowly or incompletely may not work as intended.

SUPPLX.com's Business Pill and Branch Manager for Men dietary supplements contain yohimbine that is not listed on the labels. FDA testing found dangerously high levels of this substance, which can cause serious heart problems, severe high blood pressure, and other dangerous side effects—especially in people taking stimulants or certain medications.

American Regent is recalling three lots of epinephrine injection (1 mg/mL multi-dose vials) due to leaking and cracked vials, plus contamination with particles including nylon, cellulosic, acrylic, polyethylene, and glass. These particles can block blood vessels, cause blood clots, and damage organs; cracked vials also risk loss of sterility and bacterial contamination. No adverse events have been reported so far.

B. Braun Medical Inc. is recalling three lots of 0.9% Sodium Chloride Injection (saline solution) used in hospitals and healthcare settings. The recalled product contains particles of zinc oxide that should not be present. Intravenous fluids contaminated with particulate matter can cause serious complications including blood clots and organ damage. No injuries have been reported so far.

Lipofit Extreme Fat Burner 2.0 (Lot 25M12F, expiration 09/2027) contains undeclared fluoxetine, a prescription antidepressant, in the daytime tablets and undeclared 2,4-dinitrophenol (DNP), a toxic pesticide, in the nighttime tablets. Neither ingredient is approved for use in dietary supplements, and DNP is not approved by the FDA for any use in humans.

Vitruvias Therapeutics is recalling one lot (504950) of Thyroid Tablets, USP 30 mg because testing found the tablets may contain higher-than-intended amounts of thyroid hormone. Taking overly potent thyroid medication can cause an overactive thyroid, leading to weight loss, rapid heartbeat, chest pain, and other serious symptoms, especially in elderly people, pregnant women, and infants.

Optimal Balance Pharmacy identified elevated bacterial endotoxin levels in one lot of compounded glutathione 200 mg/mL multi-dose vials during testing. Endotoxins can cause fevers, low blood pressure, severe allergic reactions, and in serious cases, death. The pharmacy has already received reports of adverse events including fever, chills, severe headache, nausea, vomiting, and allergic-like reactions.

Schwarzkopf Professional Osis Grip extra strong mousse in 6.76 fl. oz aluminum cans may leak under pressure due to a packaging defect, creating a risk of explosion. The affected product was sold to salons and retailers across the U.S. Henkel learned of the issue through one customer complaint and two salon reports, with one instance of hand bruising reported.

Fresenius Kabi recalled one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after discovering the product contains glass particles. The affected lot was distributed nationwide to hospitals, clinics, and distributors.

Victory Medical Center Pharmacy identified elevated bacterial endotoxin levels in certain lots of its compounded glutathione 200 mg/mL multi-dose vials used for injection. Endotoxin contamination can cause serious reactions including fever, low blood pressure, severe headache, and in rare cases, anaphylactic shock or death. The pharmacy has received reports of adverse events from patients who received the product.

Medline Industries recalled Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits because the electrical connector at the Neptune humidifier can overheat, causing discoloration, melting, smoke, or burning. When this happens, the device automatically shuts off the heated wire function, which means infants may receive unheated or unconditioned breathing gas that can damage the airway and increase the risk of respiratory complications.

American Regent, Inc. Animal Health recalled four specific lots of Adequan Canine Injection (for dogs) and Adequan i.m. Injection (for horses) after discovering glass fibers in the products during internal testing. No adverse events have been reported to date.

Hair was found in Xylocaine (lidocaine HCl Injection, USP) 1% vials distributed nationwide. The affected product is Lot #6133986 with expiration date 02/2029. No injuries have been reported.

Hair was found in vials of Xylocaine (lidocaine HCl Injection, USP) 1% supplied by Fresenius Kabi. The affected product is a multiple-dose vial medication used for local anesthesia. This contamination could pose a risk if the injection is administered without detection.

Hair was found in Naropin (ropivacaine hydrochloride) injection vials used for local anesthesia. The affected product is the 0.5% concentration in 20 mL single-dose vials. Approximately 92,600 vials from Lot #6133436 (expiration 10/2028) were distributed nationwide.

Hair was found in Fresenius Kabi Lidocaine HCl Injection vials (2%, 20 mg per mL). This affects 181,225 vials nationwide with lot number 6133801 and an expiration date of January 2028. No injuries have been reported.

Hair was found in some vials of Fresenius Kabi glycopyrrolate injection. The affected product is a prescription medication used during anesthesia and medical procedures. Two lots distributed nationwide are involved.

Rising Pharma's Cyproheptadine Hydrochloride Syrup (2 mg/5 mL, 473 mL bottles) is being recalled because the medication is crystallizing and forming particles that float in the bottle. This affects specific batches distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Cool Relief may not meet sterility standards required for eye medications. The affected product was manufactured in Vietnam and distributed nationwide. No injuries have been reported to date.

Rohto Cooling Eye Drops Dry Aid (twin pack) distributed nationwide may not meet sterility requirements. The affected lots were manufactured in Vietnam and distributed by The Mentholatum Company. No injuries have been reported.

Rohto Cooling Eye Drops Dry Aid may not meet sterility standards required for eye medications. The affected product was distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Digi Eye may not meet sterility standards required for eye products. The affected lots were distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Optic Glow may not meet sterility standards required for eye products. The manufacturer cannot confirm that certain batches were manufactured under proper sterile conditions. No injuries have been reported.

Rohto Cooling Eye Drops Max Strength (a nasal decongestant eye drop product) was distributed without assurance that all units met sterility standards. The product is used directly in the eye, where any contamination could pose a risk of infection. This recall affects specific lot numbers distributed nationwide.

Rohto Cooling Eye Drops Max Strength in certain lots may not be sterile. The manufacturer cannot assure that these drops meet sterility standards required for safe eye use. No injuries have been reported.

Rohto Cooling Eye Drops ALL-IN-ONE in specific lots does not meet sterility standards required for eye products. The issue was identified during manufacturing quality checks. Affected lots are distributed nationwide and are sold in pharmacies and retailers.

Asclemed USA Inc. is recalling Lidolog Kit, which contains lidocaine injection, because the label wrap covers the barcode, making it difficult to scan. This labeling defect affects 18 kits distributed in Tennessee.

Ascend Laboratories is recalling one lot of amlodipine and olmesartan medoxomil combination tablets (10 mg/20 mg) because the olmesartan medoxomil active ingredient is below the required amount. This means affected tablets may not work as intended to lower blood pressure.