Antibiotic Recalled Over "Super Potent" Dosage—Serious Side Effects Possible, FDA Warns

A person looking at a bottle of medicine from their medicine cabinet — Boris023/iStock

Unlike over-the-counter products, we can only get access to prescription drugs including antibiotics only when doctors deem them necessary. In many cases, they're the best and quickest way to kick an infection and help a patient feel better again. But now, the U.S. Food & Drug Administration (FDA) is warning that an antibiotic has been recalled over an accidental "super potent" dosage they may contain.

In an alert posted on March 27, the agency announced that New Jersey-based Amneal Pharmaceuticals, LLC, was pulling four lots of its Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL. The affected product is packaged in 80 mL bottles with the lot number 22613003A; 150 mL bottles with the lot numbers 22613004A and 22613005A; and 300 mL-sized bottles with the lot number 22613005B. All bottles are labeled with the expiration date "09/2025."

According to the recall notice, the antibiotic "is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile." The products were distributed nationwide between Nov. 9, 2023, and Feb. 20, 2024.

Adult patients are only supposed to receive a maximum of 2 grams of the drug per day. However, a manufacturing error led to the recalled packages getting overfilled with up to four grams of the solution. Because some patients taking the drug may have inflammatory issues with their intestines that make "significant systemic absorption" more likely, they could be at risk for serious side effects—especially if they are also suffering from kidney disease or failure.

So far, there have been no reported cases of adverse medical events related to the recalled product. According to the recall notice, consumers who currently have the medicine should carefully inspect their bottle and stop using it immediately if it is stamped with one of the recalled lot numbers.

They should then reach out to the company for more information on returning the product by calling 1-833-582-0812 Monday through Friday from 8:00 a.m. to 5:00 p.m. Eastern Standard Time (EST), or email [email protected]. They should also contact their doctor if they believe they've experienced any health issues from taking the antibiotic.

This isn't the only time recently that dosage issues have led to a recall. In February, the FDA announced that Nordic Naturals had pulled one lot of its Nordic Naturals Baby's Vitamin D3 Liquid, 0.76 fl. oz (22.5 mL), 400 IU (10mcg) D3 vitamin D supplements from stores. The notice said that a "manufacturing error" had led to "an elevated Vitamin D3 dosage" that could cause potentially serious side effects in babies, including vomiting, loss of appetite, increased thirst, frequent urination, and "inability to thrive."

Zachary Mack Zach is a freelance writer specializing in beer, wine, food, spirits, and travel. He is based in Manhattan.Read moreFiled UnderMedicine • News • Recall • SafetySources referenced in this article