Lupin Prednisolone Acetate Ophthalmic Suspension Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Lupin Pharmaceuticals Inc. is recalling over 2.5 million bottles of prednisolone acetate ophthalmic suspension due to the presence of a foreign substance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Lupin Pharmaceuticals Inc. initiated a voluntary recall of prednisolone acetate ophthalmic suspension due to the presence of foreign substance. The recall is classified as Class II by the FDA and affects products distributed nationwide.
Which Products Are Affected
The recall covers prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile in the following sizes:
- 5 mL (NDC 70748-332-02)
- 10 mL (NDC 70748-332-03)
- 15 mL (NDC 70748-332-04)
A total of 2,530,182 bottles are affected. Specific lot numbers and expiration dates are listed in the recall notice. The recalling firm is Lupin Pharmaceuticals Inc., Naples, FL. Recall number D-0655-2026. Distribution was U.S. Nationwide.
What You Should Do
Consumers should refer to the FDA recall notice for lot-specific information and contact their healthcare provider or pharmacist regarding affected products.
Why This Matters
The presence of foreign substance in an ophthalmic product may pose risks to users requiring prescription eye medication.
Source
FDA Enforcement Report - Recall D-0655-2026, Lupin Pharmaceuticals Inc.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,149 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.