HHP Medication Safety Watch: April 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

Male sexual enhancement products recalled due to prescription medicine contamination

• ForeverMen supplements (maker: FAonline Inc.)
• Schwinnng Capsules (maker: STOP CLOPEZ CORP)

Comment: The maker recalled these products after FDA testing found they were tainted with sildenafil and tadalafil or nortadalafil.

Sildenafil, tadalafil, and nortadalafil 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.

Hand sanitizers recalled due to contamination with methanol

• Aruba Aloe Hand Sanitizer Gel Alcohol 80% (maker: Aruba Aloe Balm N.V.)
• Aruba Aloe Alcoholada Gel (maker: Aruba Aloe Balm N.V.)

Comment: The maker recalled these hand sanitizers because of contamination with methanol (wood alcohol). Drinking a product that contains methanol can cause nausea, vomiting, headache, or blurred vision. More severe toxicity includes permanent blindness, seizures, coma, brain damage, or death. In rare cases, toxicity could develop from applying contaminated hand sanitizer to the skin.

Infants and young children are at particular risk of accidental poisoning by these products. People with alcohol addiction and teens are also at increased risk.

See additional FDA recalls and alerts for more than 660 hand sanitizer products in recent years due to methanol contamination, bacterial contamination, inappropriate labeling, or other problems.

Prescription medicines

Antibiotic recalled due to possible bacterial contamination

• AVpak Atovaquone Oral Suspension, 750mg/5mL (maker: AvKARE, LLC)

Comment: The maker of this antibiotic recalled one lot due to possible contamination with bacteria called Bacillus cereus. Using this product could cause serious or even life-threatening infections, especially among people with a weakened immune system.

Atovaquone is prescribed to prevent and treat a rare type of pneumonia caused by the fungus Pneumocystis jirovecii.

Metabolic disorder treatment recalled due to discoloration and reduced potency

• Dr. Reddy's Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg (maker: Dr. Reddy's Laboratories, Inc.)

Comment: The maker of this product recalled six lots after customer complaints and tests revealed powder discoloration and reduced potency for the medicine.

This medicine is prescribed for people with phenylketonuria (PKU). This rare metabolic disease prevents the body from breaking down the amino acid phenylalanine. Without treatment, people with PKU have high levels of phenylalanine in the body, which leads to serious neurologic problems described below.

Sapropterin lowers phenylalanine levels. Reducing potency can lead to undertreatment and increased levels of phenylalanine. Over time, too much phenylalanine can lead to brain damage, delayed development, and seizures in infants and children. During pregnancy, it can cause serious brain and heart abnormalities in the fetus.

Read additional issues of HHP Medication Safety Watch