The Food and Drug Administration announced the recall of millions of bottles of eye drops because they may contain a foreign substance.
The agency classified the recall as a Class II, meaning it is "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."
In an enforcement report, the FDA said the recall affects prednisoLONE Acetate Ophthalmic Suspension, USP, 1%.
The eye drops are used “to treat non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns,” the Mayo Clinic said.
The prescription eye drops came in three sizes: 5 mL (NDC 70748-332-02), 10 mL (NDC 70748-332-03) and 15 mL (NDC 70748-332-04).
The list of recalled lot numbers with expiration dates can be found here.
The eye drops were made by Lupin Pharmaceuticals and were initially recalled on June 4, but the FDA made the classification on June 30.
©2026 Cox Media Group
