The Cleveland Clinic explains high doses can come with outsized risk—at times "fatal," they say—compared with other types of antihistamine.
After more than a year, the U.S. Food and Drug Administration (FDA) announced this week that a recall affecting nearly 120,000 units of over-the-counter (OTC) allergy medications produced by BLI International, Inc. has now been completed. According to an October, 2024 recall notice, 4,901 cases of the tablets, each containing 24 bottles for a total of 117,624 bottles, were sold to private label customers in Ohio and Missouri “as a final packaged product.”
This week’s “completed” status update may suggest the recall event has “reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections,” the FDA notes.
“Private label” typically means the item was made by a manufacturer then sold under a better-known brand name, often as a generic or retail-brand, budget-friendlier alternative to a recognizable brand. Though the recall announcement didn’t cite a connection with a specific brand, Chlorpheniramine Maleate products are sold under store names such as Walmart’s Equate, CVS Health, and others.
The affected drugs—four-milligram (possibly labeled 4 mg) tablets of Chlorpheniramine Maleate—are used to temporarily relieve allergy symptoms such as sneezing, runny or stuffy nose, and itchy eyes. This variety of antihistamine works “by blocking histamine, a substance released by the body during an allergic reaction,” the Cleveland Clinic explains.
The affected items were manufactured for Athlete’s Needs, a Novi, Michigan-based company which, according to its Better Business Bureau listing, deals in “wholesale health products” and “health products” with distribution to Northwest/West Central Ohio and Southeast Michigan. The recalled antihistamines are reported to bear the following product details:
- National Drug Code (NDC): 53185-277-24
- Lot Number: 24A27724
- Expiration Date: January 31, 2027
“Superpotency” was listed as the reason for the recall—meaning that testing revealed the drugs to have more than the standard amount of active ingredient, exceeding acceptable limits. The Cleveland Clinic explains that high doses of Chlorpheniramine can come with outsized risk compared with other types of anti-histamines: “The toxicity of antihistamines varies greatly depending on the type,” Clinic experts say. “But first-generation H1 antihistamines (the ones that make you drowsy) are most likely to lead to antihistamine overdoses,” they write.
On October 30, 2024, the incident was classified as a Class II recall, meaning use of the product “may cause temporary or medically reversible adverse health consequences or where the possibility of serious adverse health consequences is remote.”
While no further action is required at the consumer level for this particular recall, the incident serves as a reminder that antihistamine overdose can be serious health concern. According to the Cleveland Clinic, symptoms can include:
- Intense drowsiness
- Hallucinations
- Agitation and irritability (more common in children than adults)
- Blurred or double vision
- Fast heart rate (tachycardia)
- Seizures
“If you or your child has these symptoms, call 911 (or your local emergency number) or get to the emergency room as soon as possible. A severe antihistamine overdose can be fatal if it’s not treated,” the Cleveland Clinic suggests.
For daily wellness updates, subscribe to The Healthy newsletter and follow The Healthy on Facebook and Instagram. Keep reading:
- The FDA Just Updated a High-Risk Pasta Recall Affecting 15 States
- 2 Popular Holiday Treats Have Been Recalled From a Budget Grocery Store Nationwide
- Walmart and Sam’s Club Just Recalled Cheese in a Total of 31 States and Washington, D.C.
- A Popular Dairy Brand Just Recalled Milk Gallons in 2 States, Reports the FDA
