Safety Alerts and Recalls

Safety Alerts & Recalls

Weight Loss Caps Contain Withdrawn Drug

The Food and Drug Administration (FDA) is warning consumers to not buy or use Slim-Vie, a supplement marketed for weight loss.

Rare Brain Infection May Be Linked to MS Drug

The FDA has issued a warning about one patient with multiple sclerosis (MS) being treated with Tecfidera (dimethyl fumarate; Biogen Idec) who developed progressive multifocal leukoencephalopathy (PML) and later died.

Laparoscopic Power Morcellators Get Safety Labeling Update

The Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in hysterectomy or myomectomy procedures for the majority of women.

Empty Gabapentin Capsules Prompt Recall

Aurobindo Pharma announced a voluntary recall of one lot Gabapentin Capsules 300mg at the consumer level due to the discovery of some empty capsules.

Mislabeling Leads to Recall of Highly Concentrated Potassium Chloride

Baxter announced a voluntary recall of one lot of Highly Concentrated Potassium Chloride Injection 10mEq/100mL at the user level due to a complaint of mislabeling of the overpouch.

Hidden NSAIDs Found in Herbal Supplement

The Food and Drug Administration (FDA) is warning consumers not to buy or use "Feng Shi Ling," a product marketed as an herbal drug for pain due to rheumatoid arthritis and osteoporosis.

Undeclared Ingredients Prompt Weight Loss Supplement Recall

REFA Enterprises, LLC announced a voluntary recall of Forever Beautiful Bee Pollen and Forever Beautiful Infinity products after they were found to contain undeclared ingredients. Both products are marketed as dietary supplements for weight loss.

Fungus Found in Infant Powder Supplement

Solgar announced a voluntary recall of ABC Dophilus Powder due to the discovery of Rhizopus oryzae, which may cause Mucormycosis.

FDA Questions Therapeutic Equivalence of Two Generic ADHD Drugs

The Food and Drug Administration (FDA) has expressed concerns about the therapeutic equivalence of 2 generic versions of Concerta (methylphenidate HCl extended-release; Janssen) tablets indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

Undeclared Corticosteroid, Antihistamine Found in Supplements

The Food and Drug Administration (FDA) is warning consumers not to buy or use Mayhem, a dietary supplement marketed to increase appetite and muscle growth after it was found to contain an undeclared corticosteroid and antihistamine.