Yes — there is an active recall. 1 ongoing FDA recall mention Polidocanol (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 Polidocanol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Presence of Particulate Matter
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
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.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
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