Millions of eye drops recalled over foreign substance risk

More than 2.5 million prednisolone acetate eye drops recalled nationwide by the FDA after the agency cited a foreign substance that may affect sterility. Lupin Limited manufactured the prescription drops, and regulators classified the nationwide pull as a Class II recall on June 30. The FDA warns the contamination could cause temporary or medically reversible health effects.

Key Takeaways

• More than 2.5 million bottles of prednisolone acetate eye drops are under a nationwide FDA recall.
• The recall was triggered by a foreign substance that may compromise sterility in affected lots.
• The FDA labeled the action a Class II recall on June 30, the second-highest risk level.
• Affected products are Prednisolone acetate ophthalmic suspension, USP, 1%, in 5-mL, 10-mL, and 15-mL bottles.
• Patients should check their medicine cabinet and talk to a pharmacist or doctor before stopping treatment.

Why were these eye drops recalled?

According to the U.S. Food and Drug Administration, the prednisolone acetate eye drops were recalled due to the presence of a foreign substance. More than 2.5 million bottles have been pulled nationwide because the contamination may affect sterility, according to NJ.com.

The eye drops were produced by Lupin Limited, an India-based company that specializes in producing generic pharmaceutical drugs. The Hill reports that millions of bottles are involved in the nationwide action tied to the potential foreign substance.

Which eye drop bottles are affected?

The recall covers bottles of Prednisolone acetate ophthalmic suspension, USP, 1%, according to the FDA. The affected bottles come in 5-mL, 10-mL, and 15-mL quantities.

If you use this medication, check the label on your bottle and compare it with the FDA recall notice. Because millions of units were distributed nationwide, verifying lot numbers is the fastest way to confirm whether your supply is part of the recall.

How serious is a Class II FDA recall?

The FDA labeled the recall a Class II recall on June 30, meaning the product may cause temporary or medically reversible adverse health consequences. MassLive describes Class II as the second-highest risk level on the FDA recall scale.

Using affected drops before confirming your bottle is safe is not recommended. NJ.com advises patients to consult a pharmacist or healthcare provider before making any changes to their treatment.

What should patients do if they have these drops?

Health officials say anyone with prednisolone acetate eye drops at home should check their medicine cabinet now. Do not discard or stop using the medication until you confirm whether your specific bottle is included and speak with a healthcare professional.

The FDA maintains public recall records where patients can verify lot numbers and expiration dates. For broader consumer safety coverage, see our Fintech & Crypto Alerts section. You can also review active drug recalls on the FDA recalls page.