FDA Classifies Lupin's Prednisolone Acetate Eye Drops Recall as Class II Over Foreign Particulate Contamination
核心洞察
The FDA has classified a voluntary recall of over 2.5 million bottles of prednisolone acetate ophthalmic suspension, USP, 1% as Class II, the second-highest risk level.
Lupin Limited initiated the recall on June 4 after a single market complaint from distributor Hilco Vision (搜索) reported foreign particulate matter in the product.
The foreign substance could potentially cause inflammatory responses, mechanical irritation, corneal injury (搜索), and secondary ocular inflammation (搜索), according to a Health Hazard Assessment.
More than 2.5 million bottles of prednisolone acetate ophthalmic suspension, USP, 1% are being recalled nationwide after the FDA identified the presence of a foreign substance in the product. Lupin Limited, the India-based multinational pharmaceutical company that manufactures the eye drops, initiated the voluntary recall on June 4, with the FDA subsequently classifying it as a Class II recall — the second-highest risk level — at the end of the month.
The recall encompasses 2,530,182 bottles across three packaging sizes: 5 mL, 10 mL, and 15 mL. Affected lot codes carry expiration dates ranging from July 31, 2026, to March 31, 2028, and the recall is tracked under FDA recall number D-0655-2026.
What Triggered the Recall
The basis for the nationwide action is a single market complaint alleging foreign particulate matter in the product, reported through a product recall notification from Hilco Vision (搜索), a distributor of the prescription eye drop. According to a Health Hazard Assessment cited by the FDA, the presence of this foreign substance could potentially lead to inflammatory responses, mechanical irritation, corneal injury (搜索), inflammation, and a potential risk of secondary ocular inflammation (搜索).
The FDA's enforcement report does not specify what the foreign substance is or how it entered the manufacturing process. Glance reported reaching out to Lupin directly for additional information but had not received a response as of the time of publication.
Understanding the Class II Classification
A Class II recall, as defined by the FDA, describes a situation in which "use of or exposure to a violative product" could potentially cause temporary or medically reversible adverse health consequences, or where there is a remote probability of serious adverse health consequences. This classification generally does not require consumers to immediately stop using an affected product unless the manufacturer has issued separate guidance suggesting otherwise.
The Drug and Its Manufacturer
Prednisolone acetate ophthalmic suspension, USP, 1% received FDA approval via an abbreviated new drug application (ANDA) in August 2024 as a generic equivalent of Allergan, Inc.'s (AbbVie's) Pred Forte. It is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, and is commonly used to treat allergies and eye inflammation, as well as post-surgical ocular inflammation (搜索).
Lupin Limited manufactures the drug at a facility in Pithampur, India, with distribution in the United States handled by its wholly-owned subsidiary, Lupin Pharmaceuticals, Inc.
Affected Product Identification
The affected National Drug Codes (NDCs), printed near the barcode on the bottle, are as follows: NDC 70748-332-02 for 5-mL bottles, NDC 70748-332-03 for 10-mL bottles, and NDC 70748-332-04 for 15-mL bottles. Because the recall spans dozens of individual lot codes, matching the NDC alone is insufficient to determine whether a bottle is affected. Consumers should check the specific lot number printed near the expiration date against the full list in the FDA's enforcement report.
Distributor Response and Recommendations
Hilco Vision (搜索) notified its customers of the voluntary recall just days after it was first initiated, emphasizing that "only the specific lots" it shipped — including items #1315797 and #1315798 — are subject to the recall. The company recommended that eyecare providers in possession of the recalled drops immediately discontinue use and quarantine the product, notify all staff and customers to whom the affected product was distributed, and contact RecallNotification@hilco.com if they dispensed the affected product to a patient.
Clinical Guidance for Patients
Unlike a contaminated oral medication, a compromised eye drop is applied directly to the eye, bypassing some of the body's natural defenses. Physicians and the FDA caution against stopping a prescribed steroid eye drop abruptly, as discontinuing treatment for eye inflammation can cause its own complications. Anyone with an affected bottle should contact their prescribing doctor or pharmacist before making any changes. A physician can arrange a replacement from an unaffected lot or prescribe an alternative medication if needed.
Patients experiencing eye pain, redness, irritation, or vision changes after using the product should contact a doctor promptly. Adverse reactions can be reported directly to Lupin Pharmaceuticals at 1-800-399-2561 or to the FDA's MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.