RECALLS & HEALTH ALERTS
Eye Drops and Ointment Recall
Specific eye products made by Sterling Pharmaceutical Services lack assurance of sterility. Check the brand, product, and lot before using them.
Notice checked:
Check the official recall details ↗
Recall details can change. Check the official notice for the complete affected-product list and current instructions.
Which eye products are included?
The FDA record for event 99712 includes specific 15 mL lubricant eye drops, some twin packs, Reliable-1 5% sodium chloride solution, and Major LubriFresh P.M. nighttime ointment in 3.5 g tubes. Major ointment lot 3183 is included; the FDA entry does not supply its expiration date.
Other products have multiple affected lots. Match the exact product, package size, NDC, and lot code in the FDA record. For example, TRP Gentle Eyes NDC 17312-430-15 lists lots 3279 and 3292. This example is not the complete recalled-product list.
Why was it recalled?
The voluntary recall began August 20, 2026, and was classified Class II on September 21. FDA lists lack of assurance of sterility as the reason. That concern warrants following the recall instructions, even when contamination in a particular bottle has not been confirmed.
What should you do?
Stop using a matching lot. Ask a pharmacist or retailer about a replacement or return. FDA’s eye-drop safety guidance advises stopping drops that cause discharge, pain, vision changes, or discomfort, and contacting a doctor about unexpected effects. Do not substitute another medicated eye product without checking whether it suits your condition.
Frequently asked questions
Are all eye drops from these brands recalled?
No. Compare the specific formulation, size, NDC, and lot code in the official recall record.
Does lack of sterility assurance mean contamination was proven?
No. It means the required assurance is lacking. Follow the recall instructions even when contamination has not been confirmed.
About this notice
Topic suggested by Health.com’s eye-product recall coverage. Product details and instructions are drawn from the official sources linked above. This notice provides general safety information and does not replace medical advice.