Parents who are concerned their child might be suffering from pain or fever will want to double check the type of pain relief they're giving their children as baby ibuprofen has been voluntarily recalled from popular stores across the country.
UPDATE #2: Please note the baby ibuprofen included in the voluntary recall, initially announced in November 2018, sold at CVS, Walmart, and Family Dollar, have all since expired. The affected products expired in February 2019, April 2019, August 2019, and December 2019.
UPDATE #1: On Jan. 29, 2019, the FDA expanded its recall of infant liquid ibuprofen sold at Walmart and CVS. Three new lots were added to recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml; the update did not include baby ibuprofen sold at Family Dollar. You can see a full list of the recalled products here.
EARLIER: Tris Pharma Inc. — a Monmouth Junction, New Jersey-based company — recalled three separate lots of its infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL on Thursday. The affected items were manufactured by Tris Pharma and distributed by a separate entity to Walmart, Family Dollar, and CVS stores across the country. These products were sold under the generic brand in each of stores.
According to a press release regarding the voluntary recall, the product in question could have higher concentrations of ibuprofen, which could cause potential complications for little ones. "There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury," according to Tris Pharma's press release. "Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects."
Romper's requests for further comment on the recall from Tris Pharmacy, CVS, Family Dollar, and Walmart were not immediately returned.
As of Thursday, Dec. 6, no reports of any customers suffering from adverse effects have been shared, as noted in the press release. To prevent any possible issue, wholesalers and retailers are expected to take the affected lots of product off the shelf.
If you are concerned that you might have purchased a recalled batch of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, here's how to check.
The affected product at Walmart
- Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
- Expiration dates: 02/19, 04/19, 08/19
- Lot numbers: 00717009A, 00717015A, 00717024A.
The affected product at CVS Pharmacy
- CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle,
- Expiration date: 08/19
- Product number: 00717024A.
The affected product at Family Dollar
- Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
- Expiration date: 08/19
- Product number: 00717024A.
You can also refer to these images of the recalled medicines shared in the press release.
If you find that you have purchased the recalled infant ibuprofen, you can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8 p.m. ET to 5 p.m. PT) or via email through its Customer Service Email. Further, if you're concerned that you might have administered the recalled fever and pain reducer to your child, you should contact your physician or a health care provider as soon as possible.
While there have not been any reports of injury, taking a higher dosage of ibuprofen than is necessary can make small children ill and potentially cause serious stomach and kidney damage, according to Kids Health. So be sure to check your medicine cabinets ASAP.
