Tris Pharma, Inc., recently expanded the recall of their ibuprofen liquid drops (50mg per 1.25 mL) to the retail level, possibly impacting products already at the consumer level.  Specifically, such drops were found to potentially contain higher than labeled ibuprofen concentrations.  The recall specifically involves six lots of product, which were found to have up to 10% higher concentrations of ibuprofen.  Typically far higher concentrations would be needed to cause toxicity, nevertheless it may be possible that some infants have circumstances where smaller exposures could still prove detrimental. 

The recalled products are marketed under CVS, Wal-Mart, and Family Dollar store brands:

• CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 & 1 oz. bottles

• CVS Health: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle

• Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle

• Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle

• Family Wellness: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle

Consumers may choose to discuss further details of this recall with you, their pharmacist, or by contacting the company directly via Tris Customer Service: 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT).

To view the FDA safety recall announcement, including pictures of the product boxes and labeling, click here: https://www.fda.gov/Safety/Recalls/ucm630112 .