The FDA has issued a voluntary recall of over 2.5 million bottles of prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, a prescription-based eye drop manufactured by Lupin Limited and distributed across the United States.
A retail-level recall was originally issued in early June before receiving a Class II recall level by the FDA at the end of the month.
First, refresh me on this specific eye drop.
The prednisolone acetate eye drop was granted FDA approval (via an abbreviated new drug application [ANDA]) in August 2024 as a generic equivalent of Allergan, Inc’s (AbbVie’s) Pred Forte.
- Its indication: For the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe
- In other words: It’s commonly used to treat allergies and eye inflammation.
- See its full prescribing information.
And its manufacturer?
Lupin is an India-based, multinational pharmaceutical company with a broad portfolio of branded and generic formulations.
- Take note: Its U.S. wholly-owned subsidiary is Lupin Pharmaceuticals, Inc.
Also: While the generic drop is not appearing in the company’s website product list, it is still listed in Lupin’s downloadable product catalog.
Noted. Now to the details of this recall.
The FDA noted that the “presence of a foreign substance” led to the nationwide recall, with an initiation date (by Lupin, take note) of June 4.
The basis for this: Is reported to be a single market complaint alleging foreign particulate matter in the product—which (based on a Health Hazard Assessment) could potentially lead to:
- Inflammatory responses
- Mechanical irritation
- Corneal injury
- Inflammation
- Potential risk of secondary ocular inflammation
Where did that report come from?
It’s actually based on a product recall notification from Hilco Vision, a distributor of the prescription-based eye drop.
- Glance also reached out to Lupin directly for more information on this. As of the time of publication, the company has not responded to our request.
And which bottles are affected?
A total of 2,530,182 bottles of prednisolone acetate eye drops, packaged in three different sizes (5 mL, 10 mL, and 15 mL).
Their respective national drug codes (NDCs), lot codes, and expiration dates—which range from July 31, 2026, to March 31, 2028—can be found here.
Let’s talk about that Class II level classification—what does that mean?
This FDA-assigned classification translates to a situation in which the “use of or exposure to a violative product” could potentially cause:
- Temporary or medically reversible adverse health consequences
- A remote probability of serious adverse health consequences
In general: Providing a manufacturer has not issued a separate guidance suggesting otherwise, this FDA classification does not usually require consumers to immediately stop the use of an affected product.
Gotcha. So where have the drops been sold?
Good question. We reached out to Lupin for insights on this and are still awaiting a response.
One distributor we can confirm: The aforementioned Hilco Vision, who notified its customers of the voluntary recall just days after the recall was first initiated.
The company emphasized that “only the specific lots” it shipped (including items #1315797 and #1315798) are subject to the recall.
Among Hilco’s recommendations for eyecare providers (ECPs) 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.
- If an ECP dispensed the affected product to a patient, they should contact RecallNotification@hilco.com immediately.
Have there been any other reports of infections or contamination from these drops?
Aside from that initial report kicking off this recall in the first place?
Not so far … however, if any consumers or ECPs do have adverse events to report, they should submit a form online via the FDA’s MedWatch Adverse Event Reporting program or by mail/fax.