HHP Medication Safety Watch: June 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 health care 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

Remedies for colds and teething  recalled due to fungal contamination

• Zicam Cold Remedy Nasal Swabs (maker: Church & Dwight Co., Inc.)
• Zicam Nasal AllClear Swabs (maker: Church & Dwight Co., Inc.)
• Orajel Baby Teething Swabs (maker: Church & Dwight Co., Inc.)

Comment: The maker of these products has recalled all lots because of potential fungal contamination that could pose a serious health risk. The risk may be highest (and even life-threatening) to users with inflammation inside the nose or an impaired immune system.

These products are marketed as treatments for the common cold, nasal cleansing, and teething pains in infants and toddlers.

Prescription medicines

Anti-nausea patch may cause dangerous increase in body temperature

• Transderm Scōp (Scopolamine Transdermal System)

Comment: The anti-nausea patch, Transderm Scōp, may increase body temperature (hyperthermia) and cause heat-related illness, according to a warning from the FDA. This medicine can alter the body’s ability to regulate temperature and reduce sweating, both of which can lead to hyperthermia. Serious complications may follow, including loss of consciousness, coma, or even death. The risk appears to be highest in children, teenagers, and adults ages 60 and older, especially in warm environments. Most cases developed within 72 hours of patch application among teenagers and kids using it for the first time.

Because of the risk of hyperthermia, the FDA warning recommends avoiding using the Transderm Scōp patch in warm settings or with external heat sources (such as a heating pad or blanket). Anyone using this patch who experiences higher body temperature, reduced sweating in warm surroundings, or other symptoms of hyperthermia should immediately remove the patch and seek medical attention. Even after patch removal, the effects may last hours to days while the absorbed medicine remains in the body.

Concerns about hyperthermia also apply to generic versions of this medicine.

Antibiotic tablets recalled due to microbial contamination

• Amneal sulfamethoxazole/trimethoprim tablets, 400 mg/80 mg (maker: Amneal Pharmaceutical LLC)

Comment: The maker of this antibiotic has recalled three lots because the tablets may be contaminated with a fungal microbe, Aspergillus. This fungus can cause serious and even life-threatening infections, especially among people with impaired immune function.

The antibiotic tablets affected by this recall are prescribed for a number of bacterial infections, including urinary tract infections, ear infections in children, and traveler’s diarrhea.

Read additional issues of HHP Medication Safety Watch