Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cyclopentolate Hydrochloride Ophthalmic Solution USP Recalled by Bausch & Lomb, Inc. Due to Labeling: Incorrect or Missing Package Insert: Package insert...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bausch & Lomb, Inc. directly.
Affected Products
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
Quantity: a) 905,956 Bottles, b) 191,375 Bottles
Why Was This Recalled?
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bausch & Lomb, Inc.
Bausch & Lomb, Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report