Last week, a recall for 1.8 million eye drops went into effect. Now another product is under scrutiny...but for a different reason.
60,000 More Eye Drops Have Been Recalled Nationwide
Published on May 11, 2025
Eye drops offer relief for a variety of problems ranging from irritating to serious, and ophthalmologists use them to treat everything from inflammation to eye infections, according to the American Academy of Ophthalmology. And for more than 4 million Americans living with glaucoma, certain eye drops help manage the condition by lowering pressure in the eye.
After a huge recall event last week for nearly 2 million eye drop products aimed at alleviating dry eyes, there’s another warning from the U.S. Food and Drug Administration (FDA)—this time for eye drops with the purpose of helping individuals with glaucoma.
On Monday, May 5, the FDA released new information regarding a nationwide recall for 60,428 total bottles of Timolol Maleate Ophthalmic Solution eye drops, which are typically used to treat glaucoma. The eye drops appear to only be available via a prescription.
The recall, which apparently went into effect on April 18 but wasn’t classified by the FDA until last week, reportedly went into effect because of a defective container issue. Specifically, the FDA lists the reason as “unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.”
The provided product details are:
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile
- 10mL bottles
- Rx only
- Lot #: 083I098
- Expiration Date: 08/31/2025
- Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India
- Distributed by: Rising Pharmaceuticals Inc, New Jersey
- National Drug Code (NDC): 64980-514-01
The manufacturer, FDC Limited—also listed as the recalling firm—has been producing healthcare products since 1936, and their website shows they manufacture multiple kinds of eye drops and other types of medication.
There is no cure for glaucoma—a type of eye disease that can result in either vision loss or blindness—but “early treatment can often stop the damage and protect your vision,” says the National Eye Institute.
There are several risk factors for developing glaucoma, including being over the age of 60 or having certain health conditions such as diabetes, high or low blood pressure, or heart disease.
The FDA says the recall is a Class II event, meaning temporary or medically reversible adverse health effects may occur if using the products.
FDC Limited has a page online where you can report any adverse effects or product complaints.
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