Lupin Pharmaceuticals recalls 2.5M prednisolone eye drop bottles over contamination concerns

Eye drops recall overview:

• Who: Lupin Pharmaceuticals is recalling 2,530,182 bottles of prednisolone acetate ophthalmic suspension, USP, 1%.
• Why: The recall is due to the potential presence of a foreign substance in the eye drops.
• Where: The recall is effective nationwide in the United States.

Lupin Pharmaceuticals is recalling more than 2.5 million bottles of prednisolone eye drops due to the risk of contamination with a foreign substance.

The affected product, prednisolone acetate ophthalmic suspension, USP, 1%, is available in three bottle sizes: 5 mL, 10 mL and 15 mL, and is used to treat non-infectious eye allergies and inflammation.

The recall applies to several lot numbers, such as HA00937, HB00783 and HC00060, with expiration dates ranging from July 2026 to February 2028.

The recall was initiated on June 4 and was classified by the U.S. Food and Drug Administration (FDA) as a Class II recall on June 30. This classification indicates that the use of the product may lead to temporary or medically reversible adverse health consequences, with a remote probability of serious health issues.

Consumers advised to stop using affected prednisolone eye drops

Lupin Pharmaceuticals is actively working to address the issue by removing the affected products from the market and ensuring that no further contaminated batches reach consumers.

The recall notice advises consumers to stop using the product immediately and either return it to the place of purchase or dispose of it.

The eye drops are used to treat non-infectious eye allergies and inflammation, including damage from chemical and thermal burns, according to the recall.

For more information about the eye drops recall, consumers can contact Lupin Pharmaceuticals at its Naples, Florida, office by calling 239-316-1900 or visit the FDA’s website for further details.

Lupin Pharmaceuticals says it has not received any reports of illness or injury related to the eye drops recall so far. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

Currently, Alcon Laboratories is facing a lawsuit claiming it falsely advertises its Systane eye drops as being preservative-free when they actually contain boric acid.

Are you affected by this Lupin Pharmaceuticals recall? Let us know in the comments.

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