HHP Medication Safety Watch: September 2023

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 recalled due to contamination with a prescription drug

• WEFUN Capsules (maker: Hua Da Trading Inc/WEFUN Inc)

Comment: The maker of this product has recalled 300 boxes after FDA analysis revealed contamination with sildenafil, a prescription drug for erectile dysfunction. Sildenafil 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 product is marketed as a dietary supplement for "confidence, energy and performance."

Mouthwash for kids recalled due to contamination with yeast

• TheraBreath Kids Strawberry Splash Oral Rinse (maker: Church & Dwight Co., Inc.)

Comment: One lot of this product has been recalled after its maker discovered contamination with a type of yeast (Candida parapsilosis). Using the product could cause severe or even life-threatening infection, especially among people with a weakened immune system. Less severe infections could occur in people with normal immune function. People who recently had oral surgery or a dental procedure are at higher risk of infection.

This product is marketed as an anti-cavity mouthwash for children aged 6 years and older.

Prescription medicines

Antifungal medicine recalled due to contamination

• Brexafemme (ibrexafungerp) tablets (maker: Scynexis, Inc.)

Comment: The maker of this product has recalled two lots due to possible contamination. The contaminant could cause allergic reactions such as rash, hives, or even life-threatening anaphylaxis.

Brexafemme is prescribed to treat and prevent vaginal yeast infections (also called vulvovaginal candidiasis).

Medicine to prevent transplant rejection recalled due to crystallization

• Sandimmune (Cyclosporine) Oral Solution, 100 mg/mL (maker: Novartis Pharmaceuticals Corporation)

Comment: One lot of this product has been recalled because its maker observed that some bottles had crystal formation. This could cause the medicine to distribute unevenly in the bottle. As a result, dosing may be unreliable.

Because this medicine is taken to prevent rejection of a transplanted organ, underdosing could lead to organ rejection and loss of organ function. A higher than intended dose could cause side effects (such as high blood pressure, headache, or stomach pain) or symptoms of overdose (such as kidney or liver damage, vomiting, or swelling of the extremities).

Ulcer medicine recalled due to bacterial contamination

• Sucralfate Oral Suspension, 1g/10mL (maker: VistaPharm LLC)

Comment: The maker of this medicine has recalled one lot due to contamination with a type of bacteria (Bacillus cereus). Using this product could cause a serious or even life-threatening infection, especially among people with a weakened immune system.

This medicine is prescribed to treat peptic ulcers (commonly called stomach ulcers).

Read additional issues of HHP Medication Safety Watch