FDA Initiates Nationwide Recall of 2.5 Million Prednisolone Acetate Eye Drops

The U.S. Food and Drug Administration (FDA) has classified a voluntary recall of more than 2.5 million bottles of prednisolone acetate ophthalmic suspension as a Class II event. Manufactured by India-based Lupin Limited, the prescription eye drops are being pulled from the market due to the reported presence of a foreign substance. This recall is significant for the pharmaceutical sector as it involves a widely used generic equivalent to AbbVie’s Pred Forte and highlights ongoing quality control challenges in multinational generic manufacturing.

The recall affects 2,530,182 bottles of prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, which were distributed across the United States in 5 mL, 10 mL, and 15 mL sizes. Originally initiated at the retail level by Lupin Limited on June 4, the FDA elevated the action to a Class II recall at the end of June. The product is a generic version of Allergan’s (an AbbVie company) Pred Forte and was granted FDA approval via an abbreviated new drug application (ANDA) in August 2024. While the specific nature of the "foreign substance" found in the drops was not detailed, the recall encompasses numerous lots with expiration dates ranging from July 31, 2026, to March 31, 2028.

Lupin Limited, an India-based multinational pharmaceutical firm, is the manufacturer of the affected eye drops. Although the generic product is currently absent from the company’s website product list, it remains listed in its downloadable product catalog. Hilco Vision, a primary distributor of the prescription medication, played a key role in the process by notifying its customers of the voluntary recall just days after the initial June 4 start date. Hilco Vision emphasized that only specific lots it shipped, including items #1315797 and #1315798, are subject to the recall.

Under the FDA’s Class II classification, the agency typically does not require consumers to immediately cease use of the product unless the manufacturer provides specific guidance to do so. To date, there have been no reported adverse events linked to the foreign substance found in the prednisolone acetate bottles. However, the FDA and Lupin are monitoring the situation, and healthcare providers or consumers are encouraged to report any complications through the FDA’s MedWatch Adverse Event Reporting program. This incident underscores the regulatory scrutiny faced by generic manufacturers in maintaining sterile production environments for ophthalmic formulations.