Millions of eye drops recalled nationwide. See affected products
Millions of bottles of prescription eye drops have been recalled nationwide, according to a Food and Drug Administration enforcement report.
More than 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension eye drops were recalled because of the potential presence of a foreign substance, according to the FDA's enforcement report. Lupin Pharmaceuticals Inc. manufactured the drops.
The recall was initiated June 4 but was classified as a Class II recall June 30, according to the enforcement report. The FDA said a Class II recall applies to products that, if used or exposed to, may cause temporary or medically reversible adverse health consequences.
According to the Mayo Clinic, Prednisolone drops are used to treat mild to moderate non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns. The medicine also is used to treat inflammation of the eyes caused by certain conditions.
"Prednisolone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions," Mayo Clinic says on its website. It adds that the medicine is available only with a doctor's prescription.
Which bottles of eye drops are being recalled?
According to the FDA, the bottles being recalled are labeled as "prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only." The agency is recalling 5 mL, 10 mL and 15 mL bottles. The national drug code for each bottle size is listed below.
- 5 mL (NDC 70748-332-02)
- 10 mL (NDC 70748-332-03)
- 15 mL (70748-332-04)
The recall affects 2,530,182 bottles of eye drops manufactured by Lupin Limited, Pithampur (M.P) 454 775, INDIA. The recall number is D-0655-2026.
Dozens of lot codes and separate bottles were included in the recall, according to the FDA. To see if your prescription is affected, you can check the enforcement report at fda.gov.
What should you do with recalled eyedrops?
The FDA's enforcement report did not detail a remedy for those who have the eye drops; however, the federal agency says people should immediately stop using any recalled products. Manufacturers should notify customers who received the products about the recall and provide instructions on what to do with them, the FDA said.
USA TODAY contacted Lupin Pharmaceuticals on July 9 for information on the recall.
Gabe Hauari is a national trending news reporter at USA TODAY. You can follow him on X @GabeHauari or email him at Gdhauari@usatodayco.com.
This article originally appeared on USA TODAY: Millions of eye drops recalled nationwide. See affected products
Reporting by Gabe Hauari, USA TODAY / USA TODAY
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This story was originally published July 12, 2026 at 3:56 PM.