Nationwide Recall of 2.5 Million Eye Drops Due to Contamination

WHO:

Fox Business - Lupin Pharmaceuticals Inc. is the company involved in the recall.

NY Post - The FDA (Food and Drug Administration) flagged the eye drops for contamination.

WHAT:

Fox Business - More than 2.5 million bottles of prednisolone acetate ophthalmic suspension USP, 1%, are being recalled.

Fox Business - The exact number of bottles recalled is 2,530,182.

Fox Business - The recall is classified as a Class II recall due to concerns about foreign material found in the product.

NY Post - The eye drops were flagged due to a “potential presence of a foreign substance.”

WHERE:

Fox Business - The eye drops were manufactured in Pithampur, India, and distributed nationwide in the United States.

WHEN:

Fox Business - The FDA classified the recall as a Class II recall on June 30.

Fox Business - The recall covers lot numbers with expiration dates beginning in July 2026 and extending beyond October 2026.

Fox Business - Lupin initiated the recall on June 4.

WHY:

Fox Business - The recall was initiated due to the identification of a foreign substance in certain lots of the eye drops.

HOW:

Fox Business - Consumers and healthcare providers can compare affected lot numbers with the FDA's published enforcement report to determine whether their medication is included in the recall.

Fox Business - Patients who believe they have an affected bottle are advised to contact a pharmacist or healthcare provider for guidance.

(UPDATED July 10, 2026 01:28 UTC)

Lupin Pharmaceuticals Inc. is recalling more than 2.5 million bottles of prednisolone acetate ophthalmic suspension due to contamination concerns flagged by the FDA. The recall, which affects 2,530,182 bottles manufactured in Pithampur, India, is classified as a Class II recall because of the potential presence of a foreign substance. Consumers and healthcare providers can check the affected lot numbers against the FDA's enforcement report, and those who suspect they have an impacted bottle are encouraged to reach out to a pharmacist or healthcare provider for assistance.