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Nearly 40,000 Eye Drop Bottles Recalled Over Sterility Concerns

Created at 23 Aug · 6:26 PM1 source↑ Market-relevant
IN SHORT

Federal regulators announced a nationwide recall of nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops due to a lack of assurance of sterility. Prestige Brands Holdings initiated the voluntary recall, classified as Class II by the FDA.

Key Numbers

39,060bottles of eye drops recalled
15 mLbottle size
September 30, 2027expiration date of affected product

Who's Involved

US Food and Drug Administration (FDA)
Federal safety regulator announcing the recall
Prestige Brands Holdings
Maker of Clear Eyes Maximum Itchy Eye Relief initiating voluntary recall
Medtech Products Inc.
Distributor of the affected eye drops

↳ Why This Matters

The recall impacts consumer health by removing potentially contaminated eye drops from the market, aiming to prevent adverse health consequences.

Key facts

  • Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops are being recalled nationwide.
  • The recall is due to a lack of assurance of sterility.
  • Prestige Brands Holdings initiated the voluntary recall.
  • The FDA classified the recall as Class II.

Federal safety regulators announced a nationwide recall of nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops due to concerns about the product's sterility. Prestige Brands Holdings, the maker of the eye drops, voluntarily initiated the recall. The affected product comes in 15 mL (0.5-fluid-ounce) dropper bottles and is distributed by Medtech Products Inc., a Prestige Consumer Healthcare company. The specific product carries NDC 67172-999-01 and UPC 6 78112 65920 3. Consumers can identify the recalled bottles by Lot 2552A and an expiration date of September 30, 2027. The company initiated the recall on July 29, 2026, and the FDA classified it as a Class II recall on August 14. A Class II recall indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is considered remote. The recall remains ongoing.

Frequently asked questions

The eye drops are being recalled due to a lack of assurance of sterility, indicating a potential contamination problem.

Approximately 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief are affected by the recall.

A Class II recall is issued when exposure to a product may cause temporary or medically reversible adverse health consequences, or when the likelihood of serious adverse health consequences is considered remote.

What Happens Next

01The recall remains ongoing.

How It Developed

Prestige Brands Holdings initiated a voluntary recall of 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief.
The recall is due to concerns about the product's sterility.
The affected product is distributed by Medtech Products Inc., a Prestige Consumer Healthcare company.
The FDA classified the recall as Class II on August 14.
The recall remains ongoing.

Sources

T1
Nearly 40,000 Eye Drop Bottles Are Recalled Over Potential ContaminationThe New York Times
T2
FDA announces nationwide recall of nearly 40,000 eye-drop bottles over ...economictimes.indiatimes.com

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