2.5 million prednisolone eye drops recalled over contamination risk
FDA urges patients to check lot numbers before stopping medication
More than 2.5 million bottles of prescription prednisolone eye drops have been recalled in the United States over concerns they may contain a foreign substance. The US Food and Drug Administration (FDA) has classified the recall as Class II, meaning the products could cause temporary or medically reversible health effects.
Which eye drops were recalled?
The recall affects Prednisolone Acetate Ophthalmic Suspension USP, 1%, manufactured by Lupin Pharmaceuticals Inc.
The affected products include:
- 5 mL bottle (NDC: 70748-332-02)
- 10 mL bottle (NDC: 70748-332-03)
- 15 mL bottle (NDC: 70748-332-04)
According to the FDA, the recall covers 2,530,182 bottles.
Why were the eye drops recalled?
Lupin Pharmaceuticals initiated the recall after identifying the potential presence of a foreign substance in the eye drops.
The FDA later assigned the recall a Class II designation, indicating that use of the affected product may cause temporary or medically reversible adverse health effects, while the likelihood of serious harm is considered low.
How can you check whether your bottle is affected?
Patients should compare their medication's lot number and expiry date with the information listed in the FDA recall notice to determine whether their prescription is included.
Only bottles matching the affected lot numbers are part of the recall.
What should patients do next?
Health experts advise patients not to stop using prednisolone eye drops without medical advice.
Because the medication is used to reduce inflammation, stopping treatment abruptly could worsen certain eye conditions.
Instead, patients should contact their pharmacist or prescribing healthcare provider to discuss whether they need a replacement or an alternative treatment.
Jennifer Young, lead medication safety specialist at the Institute for Safe Medication Practices, said patients should always seek professional advice before making changes to prescription medicines following a recall.