Full Breakdown
FDA Issues Class II Recall of Lupin’s Prednisolone Eye Drops Over Possible Contamination
7/10/2026, 8:48:27 PM
Core Recall Details
The U.S. Food and Drug Administration (FDA) announced a nationwide Class II recall of 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1 % manufactured by Lupin Pharmaceuticals Inc. The recall, identified as Recall Number D-0655-2026, covers 5 mL, 10 mL, and 15 mL bottles (National Drug Codes 70748-332-02, 70748-332-03, 70748-332-04). The agency cites the “presence of foreign substance” in the product as the reason for removal. The recall was initiated by Lupin on June 4 (some reports list June 6) and was classified as a Class II recall on June 30. The FDA advises patients to stop using the medication immediately and to consult a pharmacist or eye-care professional for guidance.
Background & Context
Prednisolone acetate eye drops are a prescription corticosteroid used to treat inflammation after eye surgery, allergic reactions, chemical or thermal burns, and other non-infectious eye conditions. The medication is prescription-only and is described by the Mayo Clinic as a steroid that “relieves the redness, itching, and swelling caused by eye infections and other conditions.” This recall follows a recent, separate recall of over-the-counter eye drops by K.C. Pharmaceuticals, highlighting ongoing regulatory scrutiny of ophthalmic drug manufacturing.
Data & Statistics
- Total bottles recalled: 2,530,182 (? 2.5 million)
- Bottle sizes: 5 mL (NDC 70748-332-02), 10 mL (NDC 70748-332-03), 15 mL (NDC 70748-332-04)
- Lot distribution: 132 batches of 5 mL, 36 batches of 10 mL, 22 batches of 15 mL
- Expiration dates: July 2026 through February 2028
- Manufacturing site: Lupin Limited, Pithampur, Madhya Pradesh, India
- Recall initiation: June 4 (or June 6 per one source)
- Recall classification: Class II (moderate risk; may cause temporary or medically reversible health effects)
Official Statements & Responses
The FDA’s enforcement report states that the recall is voluntary and that the agency has not released a press statement. It urges patients to immediately stop using the affected drops and to contact their eye doctor or pharmacist for alternative treatment options. Lupin’s recall notice, posted on June 4, acknowledges the potential contamination but does not specify the nature of the foreign material. The agency also advises manufacturers to notify customers and provide disposal instructions, though no specific remedy has been detailed.
Criticism & Gaps
Critics note the lack of detail regarding the foreign substance, which the FDA and Lupin have not identified. The absence of reported adverse events and the delayed classification (four weeks after recall initiation) have been cited as areas where greater transparency could improve public confidence.
Conflicting Reports & Gaps
- Recall initiation date: Most sources list June 4, while one source reports June 6.
- Nature of the contaminant: All sources agree a foreign substance is present, but none disclose its composition or source.
- Adverse events: No reports of eye injuries or illnesses linked to the recalled product have been published.
Verbatim Quotes
- “presence of foreign substance.” — FDA recall notice
- “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” — FDA explanation (source 4)
- “Prednisolone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions,” — Mayo Clinic (source 2)
- “Per the FDA, a Class II recall applies to products that, if used or exposed to, may cause temporary or medically reversible adverse health consequences.” — FDA (source 2)
