A nationwide and cross-border recall of a popular relaxation tea, initiated after an ingredient mixup, has been designated by food inspectors as the second-highest risk level.

Herbalife International of America, which is based in Los Angeles, issued a voluntary recall of its Relaxation Tea on July 21. The recall affects 5,888 products sold online across the United States as well as in Mexico and Ecuador.

On August 6, the U.S. Food and Drug Administration (FDA) classified the recall as a Class II risk—a designation indicating products may cause temporary or medically reversible adverse health consequences.

No press release was issued and the FDA’s classification alert did not state which ingredients had been mixed up. Newsweek has contacted Herbalife via email outside of regular office hours on Thursday.

Why It Matters

The FDA’s decision to classify the recall as a Class II risk signals a significant, though not life-threatening, potential for harm. Class II recalls address situations where the use of a product could cause temporary or medically reversible adverse effects, or the probability of serious consequences is remote.

What To Know

The FDA said the recall stemmed from the use of an “incorrect ingredient received from supplier and used in manufacturing finished product Relaxation Tea.”

The items’ lot code, which is often found near the product’s bar code, is: D925507J02. The expiration date is 04/11/2027, the FDA alert said.

Herbalife advised customers not to use the affected Relaxation Tea products.

FDA inspectors assign recalls one of three classifications—Class I, Class II, or Class III—to indicate the degree of hazard to people’s health. The classifications are defined by the agency as:

• Class I – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• Class II – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

What Happens Next

Consumers who purchased Herbalife Relaxation Tea are urged to check their packaging and discontinue use of any recalled units. Customers with affected products or safety concerns are advised to contact Herbalife’s customer service or review the FDA’s recall posting for detailed guidance.