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Millions of bottles of a popular eye drop medication have been recalled — affecting users nationwide.
According to the Food and Drug Administration, some 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension eye drops were flagged — due to a “potential presence of a foreign substance.”
The manufacturers, Lupin Pharmaceuticals Inc. are voluntarily recalling the product, produced at a facility in Pithampur, India.
A voluntary recall happens when manufacturers or distributors “carry out their responsibility” to protect the public health of those who use their product.
Once a problem is identified, manufacturers should notify customers who received the affected products about the recall, and provide instructions on what to do with them, according to the FDA.
The recall covers bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, in 5-mL, 10-mL, and 15-mL sizes.
Prednisolone is a prescription-only steroid medicine, used to relieve the redness, itching and swelling caused by eye infections, and other conditions like allergies, inflammation or damage from chemical and thermal burns, according to the description from the Mayo Clinic.
The recall was initiated on June 4 but classified as a Class II recall on June 30 — meaning they pose a moderate-risk of causing temporary or medically reversible health problems.
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 official product description and national drug codes are listed below.
Product description: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only
- 5 mL (NDC 70748-332-02)
- 10 mL (NDC 70748-332-03)
- 15 mL (70748-332-04)
Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
Product Quantity: 2,530,182 bottles
Recall Number: D-0655-2026
To see if your prescription is affected, click here.
The FDA did not disclose a remedy for those who used affected eye drops — but states that individuals should stop using any recalled product immediately.
