HHP Medication Safety Watch: April 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

Multiple medicines recalled after drug maker discontinued its quality program

• Multiple common drugs, including asthma and anti-anxiety medicines and antibiotics (maker: Akorn Operating Company LLC)

Comment: More than 70 over-the-counter and prescription drugs were recalled when the drug maker discontinued its quality program after bankruptcy. Without an active quality program, the purity, strength, quality, and even identity of these drugs are uncertain. Recalled products include many common drugs such as albuterol (a treatment for asthma), artificial tears, levofloxacin (an antibiotic), and lorazepam (an anti-anxiety drug). This link provides the full list of recalled drugs.

Male sexual enhancement supplement recalled due to contamination with prescription medicines

• Pro Power Knight Plus Capsule, 2550 mg (maker: Gear Isle)
• NUX Male Enhancement Capsule (maker: Gear Isle)
• Dynamite Super Capsule, 58,000 mg (maker: Gear Isle)

Comment: The maker of these products recalled them after FDA analysis revealed contamination with sildenafil and tadalafil, prescription drugs for erectile dysfunction. Sildenafil and tadalafil 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 recalled products are marketed as dietary supplements for male sexual enhancement.

Prescription medicines

Multiple medicines recalled after drug maker discontinued its quality program

• Multiple common drugs, including asthma and anti-anxiety medicines and antibiotics (maker: Akorn Operating Company LLC)

Comment: More than 70 over-the-counter and prescription drugs were recalled when the drug maker discontinued its quality program after bankruptcy. Without an active quality program, the purity, strength, quality, and even identity of these drugs are uncertain. Recalled products include many common drugs such as albuterol (a treatment for asthma), artificial tears, levofloxacin (an antibiotic), and lorazepam (an anti-anxiety drug). This link provides the full list of recalled drugs.

Fentanyl recalled due to missing safety updates

• Fentanyl Buccal Tablets, 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg (maker: Teva Pharmaceuticals USA under the label of Mayne Pharma Inc.)

Comment: Multiple lots and strengths of fentanyl from this maker were recalled because the medication guide provided with the prescriptions did not include safety updates. These updates contain information needed to take these drugs safely.

Read additional issues of HHP Medication Safety Watch