FDA urgently recalls nearly 90,000 bottles of over-the-counter fever and pain reliever distributed nationwide

The FDA announced a recall of an over-the-counter pain reliever after the agency received complaints of contamination within the product.  

Strides Pharma, Inc. is recalling 89,592 bottles of its Children’s Ibuprofen Oral Suspension, USP, 100mg per 5mL, which was distributed nationwide. 

The recall applies to 4-ounce (120mL) bottles manufactured for Taro Pharmaceuticals. It is sold across the US but was made in India. 

The FDA announcement states it received complaints of foreign substances in the medication, including a gel-like mass and black particles.  

The recall was initiated earlier this month but was classified by the FDA on Monday.

It has been classified as Class II, indicating ‘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.’ 

The recalled products have lot numbers 7261973A and 7261974A with an expiration date of January 31, 2027. 

The Taro product is available as a generic liquid ibuprofen product but also may be sold under a brand or store name.

It is meant to be used as a pain reliever and fever reducer in children.  

It is not known how the foreign substances ended up in the medication or how many bottles are actually contaminated. 

It is also not known what the foreign substances are and what danger or health hazard they may pose if ingested.

However, objects in the liquid medication could pose a choking hazard to children taking the medication. 

No injuries or illness have been reported in connection to the recall to date. 

In December, similar pain, fever and cold relief products were also recalled over concerns of rat and bird feces contamination. 

Gold Star Distribution issued a massive recall in December – and the FDA upgraded it in January – of all FDA-regulated products held at its Minneapolis Facility after the agency found evidence of rodent feces and urine and bird droppings. 

Affected cold and flu products included DayQuil Cold & Flu, Tylenol Cold & Flu, Tylenol PM, Excedrin, Motrin, Alka-Seltzer Original, Benadryl, Advil Ibuprofen Tablets and Advil PM, among others. 

No illnesses had been reported in connection to the recall. 

However, the FDA warned: ‘Persons handling or consuming the products could become seriously ill due to adulteration from pests, including rodents, birds and insects.’

The majority of products were distributed to stores in the Minneapolis area, but some were found in Indiana, New York, Illinois and North Dakota.