Current Status: No Active Recall for Muro 128 Ointment in 2025
As of Thursday, September 25, 2025, there are no active FDA or manufacturer-issued recalls for Muro 128 5% Ointment, manufactured by Bausch + Lomb. This product is a 5% sodium chloride ophthalmic ointment used for temporary relief of corneal edema. It functions by drawing excess fluid from the cornea to reduce swelling and improve vision.
While other over-the-counter eye products have been recalled in recent years due to issues like lack of sterility, Muro 128 has not been part of these recalls. However, Bausch + Lomb did issue a warning in April 2023 regarding counterfeit versions of Muro 128 sold by unauthorized online retailers. The safety of these counterfeit products is not guaranteed.
The 2014 Muro 128 Ointment Recall: A Look Back
Although not currently recalled, Muro 128 Ointment was subject to a voluntary Class II recall in 2014. Bausch + Lomb recalled approximately 850,000 tubes in the United States, Canada, and Hong Kong.
Reason for the Recall: The recall was initiated due to increased complaints of a "gritty, sand-like feeling" after use. An investigation found that some batches had developed crystal precipitates. These crystals could cause temporary or reversible adverse health effects, including foreign body sensations, eye irritation, and corneal abrasions.
Bausch + Lomb concluded that the crystallization likely resulted from some batches being exposed to freezing temperatures during shipping, despite a "do not freeze" warning. The FDA classified this as a Class II recall, indicating that while use could cause temporary health issues, the likelihood of serious adverse consequences was remote.
Understanding Eye Product Recalls
The FDA and manufacturers issue recalls for ophthalmic products primarily due to concerns about sterility and safety, as eye medications bypass some of the body's natural defenses. Contamination in eye products can lead to serious infections or harm.
Common reasons for recalls include lack of sterility, as seen in recent recalls of various eye drops and ointments due to insanitary manufacturing conditions and positive bacterial test results. Manufacturing defects, such as faulty tube seals, and the presence of particulate matter like the crystals in the 2014 Muro 128 recall, can also trigger recalls.
Consumers can stay informed by checking the FDA's website for recall announcements.
Muro 128 Ointment vs. Solution
Muro 128 is available as both an ointment and a solution (eye drops). Both contain 5% sodium chloride for corneal edema, but they differ in application and use.
| Feature | Muro 128 Ointment | Muro 128 Solution (Drops) |
|---|---|---|
| Primary Use | Often for nighttime use for prolonged relief of overnight swelling. | Typically for daytime use, every 3-4 hours. |
| Consistency | Thick, containing lanolin, mineral oil, and white petrolatum. | Liquid saline solution. |
| Vision Impact | Causes significant, temporary blurred vision. | Minimal and brief blurred vision. |
| Application | Small ribbon applied inside the lower eyelid. | One or two drops instilled into the eye. |
| Benefit | Provides sustained osmotic action by staying on the eye surface longer. | Offers clearer vision for daytime activities. |
How to Use Muro 128 Ointment Safely
Proper use of eye medication is vital for safety and effectiveness. Always use Muro 128 under a doctor's guidance.
- Wash Hands: Clean your hands thoroughly before handling the tube.
- Avoid Contamination: Do not touch the tube tip to any surface, including your eye or fingers.
- Apply: Tilt your head back, look up, and gently pull down the lower eyelid.
- Squeeze: Apply about 1/4 inch of ointment into the created pocket.
- Close Eye: Gently close your eye and roll your eyeball to distribute the medication.
- Wipe Excess: Remove any extra ointment with a clean tissue.
- Replace Cap: Securely replace the cap immediately after use.
Temporary burning, stinging, irritation, and blurred vision are common side effects. If you experience persistent eye pain, vision changes, or redness, stop use and consult your doctor.
Conclusion
As of September 2025, there is no active recall on Muro 128 Ointment. The last major recall occurred in 2014 due to crystal formation. While other over-the-counter eye products have faced recent recalls for sterility issues, Muro 128 has not been included. Patients can use this product as directed by their doctor, but should purchase from reputable sources to avoid counterfeit products and report any adverse effects.
For the most up-to-date information on drug recalls, you can visit the FDA's Recalls, Market Withdrawals, & Safety Alerts page.
