The Food and Drug Administration (FDA) has issued a Class II recall for more than 3.1 million bottles of eye drops sold at major retailers including Walgreens, CVS, Rite Aid, and others. The recall, announced on March 3, involves products manufactured by K.C. Pharmaceuticals due to concerns about their sterility.
The recall covers eight different brands of eye drops. The largest affected batch is over 1 million bottles of Dry Eye Relief Eye Drops, which were distributed at retailers such as Rite Aid, H-E-B, Meijer, and Harris Teeter, as well as military exchanges. Other brands included in the recall were sold through chains like Kroger, Publix, Dollar General, and workplace distributors like Cintas.
Here is the breakdown of the recalled products and their estimated quantities:
- 1,023,096 bottles of Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 fl. oz. (15 mL)
- 589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl. oz. (15 mL)
- 378,144 bottles of Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl. oz. (15 mL)
- 315,144 bottles of Sterile Eye Drops Redness Lubricant (glycerin 0.25%, naphazoline HCl 0.012%), 0.5 fl. oz. (15 mL)
- 303,216 bottles of Eye Drops Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1%, tetrahydrozoline HCl 0.05%), 0.5 fl. oz. (15 mL)
- 245,184 bottles of Ultra Lubricating Eye Drops (polyethylene glycol 400 0.4%, propylene glycol 0.3%), 0.5 fl. oz. (15 mL)
- 182,424 bottles of Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL)
- 74,016 bottles of Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4%, propylene glycol 0.3%), 0.5 fl. oz. (15 mL)
The FDA classified this recall as Class II, indicating the products may cause temporary or medically reversible adverse health consequences, with serious effects being unlikely.
Why it matters
Eye drops are commonly used to relieve dryness and irritation, making their sterility critical to avoid eye infections or complications. A contamination risk could lead to adverse health effects, particularly for users with sensitive eyes or compromised immune systems. The recall covers widely distributed products available at many national and regional retailers, emphasizing the importance of consumer awareness and checking product lots.
Background
This recall follows an earlier 2023 incident involving a different manufacturer whose eye drops potentially contained bacteria. Sterility issues remain a significant concern for over-the-counter ophthalmic products, requiring stringent manufacturing and quality controls to ensure consumer safety.
Consumers with affected products are advised to discontinue use and return them to the place of purchase for a refund or disposal according to retailer instructions. The FDA continues to monitor recalls and product safety in the eye care market.
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