HHP Medication Safety Watch: March 2021

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

Hand sanitizer recalled because containers look like water bottles

• Heal the World Hand Sanitizer (maker: PNHC, LLC d/b/a Heal the World)

Comment: The makers of this product are recalling it because their containers resemble water bottles, which may increase the risk of accidentally drinking it. Because hand sanitizers contain alcohol, that could cause poor coordination, slurred speech, sedation, or even coma and death due to alcohol toxicity. In addition, alcohol can interact with many medicines and can impair driving.

Hand sanitizer recalled due to bacterial contamination

• Durisan Antimicrobial Hand Sanitizer (maker: Sanit Technologies LLC d/b/a Durisan)

Comment: Specific lots of this product may be contaminated with bacteria called Burkholderia cepacia and Ralstonia pickettii. While use of a hand sanitizer contaminated with these organisms may cause no serious harm, there is a potential risk that serious or even life-threatening infections may develop, especially among people with a suppressed immune system. Examples include severe skin infections, pneumonia or bloodstream infections.

See additional FDA recalls and alerts for more than 230 hand sanitizer products in recent months due to methanol contamination, inappropriate labeling, or other issues.

Dietary supplements for male sexual enhancement may contain undeclared prescription medications

• Imperial Extreme, 2000mg, Dietary Supplement for Male Sexual Enhancement (maker: S&B Shopper LLC)
• PremierZen Black 5000 Dietary Supplement for Male Sexual Enhancement (maker: Namoo Enterprise LLC)
• Thumbs Up 7 Blue 69K Dietary Supplement for Male Sexual Enhancement (maker: Bit & Bet LLC)
• Thumbs Up 7 Red 70K Dietary Supplement for Male Sexual Enhancement (maker: Antoto-K)
• Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night Dietary Supplements for Male Sexual Enhancement (maker: Ummzy, LLC)
• Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 Dietary Supplements for Male Sexual Enhancement (maker: Nuri Trading LLC)

Comment: According to the FDA, these products may contain sildenafil, tadalafil, and/or vardenafil, prescription medicines to treat erectile dysfunction (ED). Sildenafil, tadalafil, and vardenafil may cause a dangerous drop in blood pressure, especially if taken with nitrate medicines. Other side effects may include headache, flushing, or stomach upset.

Each of these recalled products is marketed as a nutritional supplement to improve male sexual function.

Prescription medicines

Label displays incorrect dosage of spironolactone

• BRP Pharmaceuticals spironolactone, 25 mg and 50 mg tablets (maker: Bryant Ranch Prepack/BRP Pharmaceuticals)

Comment: Some batches of this medicine have been recalled because of a labeling mix-up. Bottles labeled as having 25 mg tablets may actually contain 50 mg tablets; bottles labeled as containing 50 mg tablets may contain 25 mg tablets instead.

Spironolactone is a diuretic medication (a "water pill") most commonly taken to treat high blood pressure, heart failure, or fluid retention. Taking a higher than intended dose could cause low blood pressure, dehydration, weakness, or an elevation in blood potassium leading to a dangerous heart rhythm. Taking less than the intended dose could cause an elevation in blood pressure, fluid retention, or a low blood potassium level that could cause a dangerous heart rhythm.

Label displays incorrect dosage of telmisartan

• Telmisartan tablets, 20 mg (maker: Alembic Pharmaceuticals, Inc.)

Comment: One batch of this medicine has been recalled because a bottle labeled as containing 20 mg tablets actually contains 40 mg tablets. Accidentally doubling the dose of this medicine could lead to low blood pressure, worsening kidney function, an elevated blood potassium level, and a dangerous heart rhythm.

Telmisartan is used to treat high blood pressure.

Read additional issues of HHP Medication Safety Watch