Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% Recalled by KRS Global Biotechnology, Inc Due to Lack of Assurance of Sterility
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 KRS Global Biotechnology, Inc directly.
Affected Products
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510
Quantity: 1815 syringes
Why Was This Recalled?
Lack of Assurance of Sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About KRS Global Biotechnology, Inc
KRS Global Biotechnology, Inc has 129 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report