FDA RECALL ALERT: Drugs, Medical Devices and Foods Pulled Over Serious Safety Concerns

FDA RECALL ALERT: DRUGS, MEDICAL DEVICES AND FOODS PULLED OVER SERIOUS SAFETY CONCERNS

Morphine labeling mix-up, contaminated injectable drugs, infant breathing equipment and Salmonella concerns among latest recalls

By LCCN Staff Report

A wave of new and recently announced recalls is drawing attention from the U.S. Food and Drug Administration, including a potentially dangerous mix-up involving morphine syringes, injectable medication linked to adverse reactions, infant breathing equipment and several food products that may be contaminated with Salmonella.

Some of the recalls are nationwide, while others involve products distributed only in specific states. Consumers are being urged to check medications, medical supplies and food products against the affected brands and lot numbers.

One of the most serious recalls involves Fresenius Kabi and a lot of Morphine Sulfate Injection USP, Simplist 2 mg/1 mL. According to the company, a MicroVault labeled as containing morphine may instead contain a prefilled syringe of Dilaudid, the brand name for hydromorphone.

The mistake could have potentially deadly consequences. Fresenius Kabi said use of the incorrectly labeled product could result in serious adverse health effects, including life-threatening respiratory depression and death. Those considered particularly vulnerable include children, people with respiratory disease, patients who do not regularly use opioids and people taking other central nervous system depressants. No adverse events associated with the affected lot had been reported at the time of the announcement.

Another potentially serious recall involves compounded glutathione injections manufactured by Victory Medical Center Pharmacy in Austin, Texas. Certain lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials are being recalled after testing detected elevated levels of bacterial endotoxins.

Unlike several of the other recalls, adverse events have already been reported. The pharmacy said reports included fever, chills, severe headaches, nausea, vomiting, rapid heartbeat, blood-pressure changes, body aches and injection-site reactions. Elevated endotoxins in injectable products can potentially cause severe inflammatory reactions, hypotension, anaphylactic shock and death.

A nationwide recall also involves Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits manufactured by Medline Industries. The company received reports of sporadic electrical connector failures in certain circuits used with Neptune humidifiers. The affected connectors may show discoloration, melting, smoke, a burning odor or other evidence of thermal damage.

The equipment is used with particularly vulnerable patients — newborns and infants requiring respiratory support. Loss of the heated-wire function can result in delivery of inadequately heated or conditioned gas and increased condensation inside the breathing circuit, potentially contributing to airway obstruction, respiratory distress and other complications. Medline instructed users with affected circuits to stop using and discard them rather than return them to the company.

Food recalls are also accumulating.

Lexunder Inc., which does business as Food To Live, is recalling several green powder products because of possible Salmonella contamination. The products were sold nationwide directly to consumers and businesses through company websites and other online marketplaces.

Products identified in the recall include Food to Live Wheatgrass Powder, Organic Spirulina Powder, Organic Algae Powder Mix, Organic SuperGrass Powder and Organic Wheatgrass Powder in various package sizes and lots. Consumers should check the lot code on the back of the package below the Nutrition Facts panel and next to the barcode. No illnesses had been reported when the recall notice was issued.

Another recall is tied to a broader investigation of a multistate Salmonella outbreak associated with fresh jalapeño peppers supplied by Coast Citrus Distributors. Taylor Fresh Foods announced a recall of finished products containing jalapeños after being notified of the potential contamination.

Federal health officials identified a grower in Sinaloa, Mexico, that supplies Coast Citrus as a potential source in the outbreak. Taylor Fresh Foods said it stopped sourcing from that grower and switched to alternative suppliers. The Taylor products covered by the notice were sent to retail distribution centers in 26 states and carried “Best If Used By” dates through Aug. 16, 2026. California was not included among the states listed for distribution of those Taylor products, and the company said it was not aware of illnesses linked specifically to its recalled products.

Two additional allergen recalls appear considerably more limited geographically.

Blank Slate Creamery recalled 4.5-ounce Vegan Non-Dairy Frozen Dessert Coconut Fudge Sandwiches because they may contain undeclared egg, creating a potentially serious risk for people with egg allergies. Those products were distributed at only three locations in Ann Arbor and Brighton, Michigan, and no illnesses had been reported.

Sun Noodle of Honolulu recalled 134 packages of Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base because they may contain an undeclared fish allergen. That product was distributed exclusively in Hawaii, and no illnesses or allergic reactions had been reported.

The collection of recalls ranges from relatively limited allergen-labeling problems to potentially life-threatening medication errors. Consumers with any of the affected products should follow the manufacturer’s recall instructions and should not use a recalled drug or medical device unless directed otherwise by the recall notice or their healthcare provider.