Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Is Cyclopentolate recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Cyclopentolate (18 total). Check the affected lots below.
Most common reason: Sterility / contamination (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cyclopentolate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cyclopentolate recalls on record
none so far in 2026; 18 on record, newest first
Class III · Low risk
Tropicamide 1%
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Class II · Moderate risk
TPC Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
ADAA Cataract Drops
Lack of Process Controls
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5%…
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class III · Low risk
Cyclopentolate Hydrochloride Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class II · Moderate risk
Cyclopentolate HCL*
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Combo Eye Gel
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Phenylephrine-cyclopentolate
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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