Rhiannon Ingle
Nearly 90,000 bottles of children’s ibuprofen have been recalled across the United States.
The recall has now been raised to Class II, the second-highest level used by the US Food and Drug Administration (FDA), after reports that the medicine contained a 'foreign substance'.
A Class II recall means the product could cause temporary health issues, though the risk of serious or lasting harm is considered low.
The FDA states this category covers cases where exposure may lead to short-term or medically reversible effects, with long-term consequences unlikely.
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Earlier this month, Strides Pharma, Inc. recalled 89,592 bottles of Children’s Ibuprofen Oral Suspension, USP, following reports of a 'gel-like mass and black particles' in the product, according to the FDA.
The company handling the recall, which was initiated on 2 March, on a voluntary basis, with the FDA noting it in its Enforcement Report and assigning a centre classification date of 16 March.
The recall is for liquid children's ibuprofen that comes in bottles of 4 fluid ounces (120 millilitres).
The medicine was made in India for Taro Pharmaceuticals USA, Inc. and shipped nationwide, with affected batches carrying lot numbers 7261973A and 7261974A, with an expiry date of 31 January 2027.
No injuries or illnesses have been linked to the product so far, but parents and carers have been advised to check supplies and stop using any affected bottles straight away.
Customers should contact the retailer or manufacturer to arrange a refund or replacement.
Additional guidance on What to Expect adds: "If you think you gave your child some of the recalled medication, call your health care provider."
While the FDA has issued a Class II recall for the ibuprofen, which means using it 'may cause temporary health consequences', it adds that 'the probability of a serious health issue is remote'.
"The FDA says it's generally safe to continue using a medication under a Class II recall, but check with your provider first," What to Expert notes.
"And always check with your paediatrician before giving any medications to a child under two years old."
Ibuprofen is a common painkiller for children, with the NHS stating it's often used to treat symptoms of conditions such as colds, flu and coronavirus (COVID-19), teething, toothache, headaches, sore throat and pain from ear infections.
Ibuprofen also treats swelling (inflammation), such as aches and pains after an injury like a sprain, or because of a health condition like childhood (juvenile) arthritis.
You can also give ibuprofen to your child if they have a high temperature (fever) and they feel distressed or unwell.
For children aged three months to 12 years, ibuprofen comes as a liquid (oral suspension) or as chewable capsules.
For children aged 12 years or older, ibuprofen is available as tablets, capsules and granules that you dissolve in water to make a drink.