The FDA has announced a nationwide recall of over 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension eye drops due to the potential presence of foreign substances. The recall was initiated on June 4 and classified as Class II on June 30. The affected products include 5 mL, 10 mL, and 15 mL bottles manufactured by Lupin Pharmaceuticals. Users are advised to stop using the recalled products and await further instructions from manufacturers regarding disposal.

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Millions of eye drops recalled nationwide. See affected products

Portrait of Gabe Hauari Gabe Hauari

USA TODAY

Updated July 9, 2026, 8:26 p.m. ET

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Millions of bottles of prescription eye drops have been recalled nationwide, according to a Food and Drug Administration enforcement report.

Over 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension eye drops were recalled due to the potential presence of a foreign substance, per the FDA's enforcement report. Lupin Pharmaceuticals Inc. manufactured the affected eye drops.

The recall was initiated on June 4 but was recently classified as a Class II recall on June 30, according to the enforcement report. Per the FDA, a Class II recall applies to products that, if used or exposed to, may cause temporary or medically reversible adverse health consequences.

According to Mayo Clinic, Prednisolone eye drops are used to treat mild to moderate non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns. The medicine is also 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, adding that the medicine is only available 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 impacted by the recall, according to the FDA. To see if your prescription is affected, view the enforcement report.

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What to do with recalled eyedrops?

The FDA's enforcement report did not detail a remedy for those in possession of the affected eye drops; however, the federal agency states individuals should immediately stop using any recalled products. Manufacturers should also notify customers who received the affected products about the recall, and provide instructions on what to do with them, according to the FDA.

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.

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