HHP Medication Safety Watch: May 2025

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

Dietary supplement for joint pain recalled due to contamination with other drugs

• Unavy Acidio Hialuronico Caplets (maker: UMARY-USA)
• Umovy Acidio Hialuronico Caplets (maker: UMARY-USA)

Comment: The maker of these products has recalled all lots after testing found contamination with three other drugs: dexamethasone, diclofenac, and omeprazole.

Dexamethasone is a steroid medicine used to suppress inflammation in hundreds of conditions ranging from to brain tumors to gout. It may also reduce the ability to fight infections, increase blood sugar, elevate blood pressure, and weaken muscles and bones. If taken for more than a couple of weeks, serious withdrawal symptoms (called adrenal crisis) may develop when a person stops taking this medicine.

Diclofenac is an anti-inflammatory drug used to treat arthritis and other painful or inflammatory conditions. It can cause gastrointestinal and cardiovascular side effects and kidney or liver damage.

Omeprazole is a proton pump inhibitor (PPI) used to treat acid-related stomach conditions, including ulcers. Possible side effects include allergic reactions, diarrhea, and headache.

Dexamethasone, diclofenac, and omeprazole may cause other serious problems by interacting with other medicines.

The recalled dietary supplements are marketed to treat joint pain and arthritis.

Dietary supplement recalled due to prescription medicine contamination

• Endurance Boost with horny goat weed capsules (maker: EnShiShiXiangNiShangMaoYouXianGongSi)

Comment: The maker of this product recalled one lot after routine testing found that it was tainted with sildenafil (a prescription drug for erectile dysfunction) and propoxyphenylsildenafil, a chemical closely related to sildenafil. Sildenafil and propoxyphenylsildenafil can 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 product is sold as a nutrition supplement for male performance and energy..

Dietary supplements recalled due to prescription medicine contamination

• Male Ultra (maker: Health Fixer)
• Malextra (maker: Health Fixer)
• Electro Buzz (maker: Health Fixer)
• Ultra Armor (maker: Health Fixer)
• Male Ultra Pro (maker: Health Fixer)

Comment: The maker of these products recalled all lots after testing revealed they were contaminated with sildenafil (a prescription medicine for erectile dysfunction) and two related drugs that may have similar effects (chloropretadalafil and propoxyphenylsildenafil). These contaminants 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.

This product is marketed as dietary supplements for male enhancement.

Risk of severe itching after stopping certain allergy medicines

• cetirizine (OTC as Zyrtec, other brands)
• levocetirizine (OTC as Xyzal, other brands; also available by prescription as a generic)

Comment: The FDA warns that, rarely, long-term users of cetirizine or levocetirizine may develop severe and prolonged itching when stopping the drug. Most cases were among people taking these medicines daily for months or years. Those affected reported widespread itching that began within a few days of stopping the drug.

 People who have used these drugs daily for an extended period of time, or anyone considering doing so, should discuss this risk with their health care provider. New warning labels about this complication are under development.

Cetirizine and levocetirizine are oral antihistamines for the treatment of seasonal allergies and other allergic conditions.

Prescription medicines

FDA and CDC recommend pause in use of Chikungunya vaccine for older adults

• Ixchiq, Chikungunya vaccine (maker: Valneva Austria GmbH)

Comment: The FDA and CDC are recommending that people ages 60 and older not take the chikungunya vaccine pending further safety evaluation. This follows reports of 17 individuals in this age group developing serious heart and nervous system side effects after vaccination. Two of these individuals died.

The vaccine was approved by the FDA in 2023 and has been administered to about 80,000 people worldwide. It is intended to prevent chikungunya, a mosquito-borne viral infection that typically occurs in tropical and subtropical areas of the world. Common symptoms of chikungunya include joint and muscle pain, fever, headache, and rash.

Read additional issues of HHP Medication Safety Watch