Popular eye drops sold at Walgreens recalled over sterility concerns
Sterling Pharmaceutical has recalled 747,844 units of eye drops over sterility concerns, including more than 500,000 Walgreens-branded lubricant eye-drop products. The Food and Drug Administration classified the voluntary recall as Class II, indicating a remote probability of adverse health consequences from using the affected items. Bottles sold under several brand names were pulled after sterility checks failed at a plant in Dupo, Illinois. The manufacturer cited a lack of assurance of sterility as the primary reason for the nationwide action.
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- ✓ Sterling Pharmaceutical recalled 747,844 units of eye drops after sterility checks failed at its plant in Dupo, Illinois.
- ✓ More than 500,000 of the recalled units are Walgreens-branded lubricant eye drops.
- ✓ The Food and Drug Administration classified the recall as Class II.
- ✓ A Class II classification means there is a remote probability of adverse health consequences from use of the product.
What changed
The Food and Drug Administration elevated the voluntary recall of nearly 750,000 eye-care products to a Class II classification.
Live updates
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Sterling Pharmaceutical Recalls Eye Drops Over Sterility
Sterling Pharmaceutical has recalled 747,844 units of eye drops over sterility concerns, including more than 500,000 Walgreens-branded lubricant eye-drop products. The Food and Drug Administration classified the voluntary recall as Class II, indicating a remote probability of adverse health consequences from using the affected items. Bottles sold under several brand names were pulled after sterility checks failed at a plant in Dupo, Illinois. The manufacturer cited a lack of assurance of sterility as the primary reason for the nationwide action.
Why it matters
Sterility concerns in over-the-counter ophthalmic products draw heightened regulatory scrutiny due to the direct risk of eye infections and other complications. Federal regulators monitor manufacturing compliance to prevent contaminated medical items from reaching store shelves. Major retail chains like Walgreens frequently stock store-brand pharmaceuticals manufactured by third-party facilities.
What is confirmed
- Sterling Pharmaceutical recalled 747,844 units of eye drops after sterility checks failed at its plant in Dupo, Illinois.
- More than 500,000 of the recalled units are Walgreens-branded lubricant eye drops.
- The Food and Drug Administration classified the recall as Class II.
- A Class II classification means there is a remote probability of adverse health consequences from use of the product.
What to watch next
- Any additional statements from Sterling Pharmaceutical regarding the plant failures
- Further updates from the Food and Drug Administration on affected lots and brands
confidence 90%Sources used for this update (15)
- Newser — Yet Another Batch of Eye Drops Are Being Recalled
- USA Today — Over half a million eye drops recalled. See affected products
- People.com — More Than 500,000 Eye-Drop Products Recalled, Including Walgreens Brand, Due to Sterility Concerns
- FOX 8 News — Massive recall on eyedrops that may not be sterile
- LiveNOW from FOX — Eye drops recall: Bottles sold under several brand names may not be sterile, FDA says
- Fox Business — Popular eye drops sold at Walgreens recalled over sterility concerns
- New York Post — More than 500K Walgreens-branded eye drops recalled over sterility concerns
- Yahoo — Sterling Pharmaceutical recalls 750,000 eye drops over sterility
- www.yahoo.com — Popular eye drops sold at Walgreens recalled over sterility concerns
- www.foxbusiness.com — Walgreens eye drops recalled over sterility concerns | Fox ...
- www.yahoo.com — More Than 500,000 Eye-Drop Products Recalled, Including ...
- hoodline.com — Walgreens Eye Drops Recalled Over Sterility Concerns
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