HHP Medication Safety Watch: June 2024

This list contains selected items from the full FDA list of recalls, withdrawals, and alerts for medicines and certain health products. We've provided links to FDA information for each product and its maker. Unless otherwise noted, these actions apply only to the specific brand name of the product listed. Talk to your healthcare provider before stopping or changing any medicines or treatments that they have recommended for you.

• Over-the-counter products and medicines
• Prescription medicines

Over-the-counter products and medicines

Sunscreen recalled due to contamination with mold

• Suntegrity Impeccable Skin Sunscreen Foundation, multiple shades (maker: Suntegrity)

Comment: The maker of this product has recalled multiple lots after testing found contamination with a mold called Aspergillus sydowii. Use of this product could cause an allergic skin reaction, a skin infection, or an eye infection (if inadvertently placed into the eye). The risk of a serious infection may be higher among persons with an open wound, sunburned skin, or an impaired immune system.

This product is marketed as a sunscreen to help prevent sunburn.

Oral health products recalled due to bacterial contamination

• StellaLife Advanced Formula Peppermint VEGA Oral Care Rinse (maker: HomeoCare Laboratories Inc.)
• StellaLife Vega Oral Spray, unflavored (maker: HomeoCare Laboratories Inc.)

Comment: The maker of these products has recalled one lot of each after FDA testing found bacterial contamination. Use of these products could cause an oral infection, especially among people with oral disease or who are having dental surgery. In addition, people who are immunocompromised could develop a severe and even life-threatening infection.

These products are marketed as treatments to maintain oral health.

Male sexual enhancement products recalled due to contamination with prescription medicines

• Ram It capsules (maker: Integrity Products)
• To The Moon capsules (maker: Integrity Products)

Comment: The maker of these products recalled one lot of each after FDA testing found they were tainted with the prescription medications sildenafil and tadalafil.

Sildenafil and tadalafil are prescribed for erectile dysfunction. These drugs may cause serious side effects, including a dangerous drop in blood pressure. This risk is highest among people who are also taking heart medicines such as nitroglycerin. A sudden and significant drop in blood pressure may cause heart attack, stroke, or death.

The recalled products are marketed as dietary supplements for male sexual enhancement.

Prescription medicines

Potassium supplements recalled because they fail to dissolve properly

• Glenmark Potassium Chloride Extended Release 750 mg capsules (maker: Glenmark Pharmaceuticals, Inc.)
• Blue Point Laboratories Potassium Chloride Extended Release 750mg capsules (maker: American Health Packaging)

Comment: Multiple batches of these products have been recalled by their makers because the capsules do not dissolve as they should. This may cause hyperkalemia (high blood potassium), a condition which can lead to irregular heartbeat, muscle weakness, cardiac arrest, and death. The risk is highest among people with kidney disease, high blood pressure (hypertension), or heart failure.

Potassium supplements are prescribed for persons with low blood potassium (hypokalemia).

Read additional issues of HHP Medication Safety Watch