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US Recall of 747,844 Eye Drops Over Sterility Concerns Hits Walgreens, AvKare Brands

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In brief

Sterling Pharmaceutical Services LLC has recalled 747,844 units of eye drops, lubricating tears and an eye ointment sold under six brand names after the manufacturer could not assure the products were sterile. The FDA classified the recall, which began August 20, 2026, as Class II on September 21; Walgreens-branded drops account for more than 500,000 of the recalled units.

A US manufacturer has recalled 747,844 units of eye drops, lubricating tears and a nighttime eye ointment because it could not guarantee the products were sterile, according to recall notices cited by Hoodline, Fox Business, LiveNOW from FOX and Medical Daily. Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the recall on August 20, 2026, and the US Food and Drug Administration classified it as a Class II recall on September 21, 2026.

What is being recalled

The recall covers nine ophthalmic products sold nationwide under six brand names: Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products and Major, according to Hoodline and Medical Daily. The products include 0.5% carboxymethylcellulose sodium lubricant eye drops, lubricating tears, a sodium chloride hypertonicity ophthalmic solution and Major's LubriFresh P.M. nighttime ointment. Printed expiration dates on the affected containers run from August 2026 through July 2027, and recalled lots fall in the numeric range 3161 through 3336, per Hoodline and Medical Daily.

Recalled eye-care products by brand
Brand/productUnits recalled
Walgreens Lubricant Eye Drops (bottles + twin packs)500,714
AvKare Carboxymethylcellulose Sodium 0.5% (bottles + twin packs)120,241
Reliable-1 Laboratories (Lubricating Tears + Sodium Chloride)58,699
Major LubriFresh P.M. Nighttime Ointment34,368
Cameron Pharmaceuticals Lubricant Eye Drops19,284
TRP The Relief Products Gentle Eyes14,538
Total747,844

Why the FDA classified it Class II

The FDA lists the reason for the action as a "lack of assurance of sterility" across the affected production lots, according to Hoodline and Medical Daily. The agency's Class II designation means use of or exposure to a product may cause temporary or medically reversible health consequences, while the probability of serious harm is considered remote, as reported by Fox Business and Medical Daily.

None of the four outlets reviewed for this report cited any confirmed eye infections or other injuries linked to the recalled lots as of the date of publication.

What consumers should do

Background

This is not the first large US eye-drop recall in 2026. Hoodline reported that a California manufacturer recalled 3.1 million bottles over sterility concerns in April, and Medtech Products recalled more than 39,000 bottles for the same reason in July, before the Sterling Pharmaceutical Services action in August and September.

Questions

Which brands are affected by this eye drop recall?
The recall covers Walgreens, AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products and Major-branded eye drops, lubricating tears and an eye ointment, according to Hoodline and Medical Daily.
How many eye drop units were recalled in total?
Sterling Pharmaceutical Services LLC recalled 747,844 units across nine products; Walgreens-branded items alone account for 500,714 of those units, per Fox Business and Hoodline.
Why were the eye drops recalled?
The FDA's stated reason is a "lack of assurance of sterility" in the affected production lots, meaning the manufacturer could not confirm the products were free of contamination, as reported by Hoodline.
What should I do if I have one of the recalled products?
Stop using it, check the lot number and expiration date against the recall notice, return it to the retailer for a refund, and watch for eye pain, redness, discharge or vision changes, according to Medical Daily.
Has anyone been injured by these eye drops?
None of the reports reviewed describe confirmed injuries or infections linked to the recalled lots as of early October 2026.

Sources

  1. Hoodline — Walgreens Eye Drops Among 747,844 Units Recalled Over Sterility Fears
  2. Fox Business — Popular eye drops sold at Walgreens recalled over sterility concerns
  3. LiveNOW from FOX — Eye drops recall: Bottles sold under several brand names may not be sterile, FDA says
  4. Medical Daily — Walgreens, AvKare and Four Other Eye Drop Brands Recalled Nationwide Over Sterility Concerns: Check Your Lot Numbers

This piece was prepared with artificial intelligence and passed an automated source check before publication. If you see an error, ask for a correction. Request a correction or reply · How we make this

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