HHP Medication Safety Watch: July 2024

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

Pain reliever recalled due to missing label

• Healthy Living Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets (maker: Aurobindo Pharma USA, Inc.)

Comment: The maker of this product has recalled one lot because its label is missing. As a result, the product does not provide required drug facts, ingredients, and usage information. This may increase the risk of excessive dosing or use with alcohol that could lead to liver damage. Not knowing ingredients may increase the risk of allergic reactions. The recalled lot was sold through Amazon.com.

This product is marketed as a pain reliever for various conditions, including headaches, cold symptoms, arthritis, toothaches, and menstrual cramps.

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

• Infla-650 Herbal Dietary Supplement Capsules (maker: Guru Inc.)

Comment: The maker of this product has recalled one lot after testing found contamination with acetaminophen, diclofenac, and phenylbutazone.

Using this supplement could lead to acetaminophen overdose, possibly causing liver damage, liver failure, or death. The risk of serious side effects is increased if taken with other products containing acetaminophen, the active ingredient in Tylenol and many other pain-relief and fever-reducing products.

Inadvertent use of diclofenac could cause gastrointestinal injury (including stomach ulcers and bleeding), dangerous interactions with other medicines, and an increased risk of heart attack and stroke.

Phenylbutazone is an anti-inflammatory medicine prescribed primarily for animals. It is not approved for human use in the US. Side effects include life-threatening disorders of blood cell production.

The recalled dietary supplement is marketed as a pain reliever.

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

• Umary Acido Hialuronica, 850 mg (maker: SoloVital.com and Main Products, Inc.)

Comment: The makers of this product have recalled all lots after testing found contamination with two other drugs, diclofenac and omeprazole.

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. It can also interact with other medicines.

Omeprazole is a protein pump inhibitor (PPI) used to treat acid-related stomach conditions, including ulcers. Possible side effects include allergic reactions, diarrhea, and headache. It can also interact with other medicines.

The recalled dietary supplement is marketed to treat pain.

Prescription medicines

Clonazepam recalled due to incorrect dosage information on label

• Par Pharmaceutical Clonazepam Orally Disintegrating Tablets, 0.25 mg tablets (maker: Endo USA, Inc.)

Comment: One lot of this medicine was recalled because some labels have an incorrect dosage of (0.125 mg) instead of the actual (0.25 mg) dosage. Taking a higher than intended dose of this medicine can cause dizziness, sedation, and confusion. In people with lung disease or who already take a high dose of this medicine, life-threatening breathing difficulties may develop.

This medicine is approved to treat panic disorder and certain types of seizures.

Read additional issues of HHP Medication Safety Watch