Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Is Chlorhexidine recalled?
Yes — there is an active recall. 19 ongoing FDA recalls mention Chlorhexidine (86 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chlorhexidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Chlorhexidine recalls on record
none so far in 2026; 86 on record, newest first
Class II · Moderate risk
Chlorhexidine Gluco. 0.12% Oral Rinse
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class II · Moderate risk
PerioRx (chlorhexidine gluconate)
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
Chlorhexidine gluconate
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
ORIS (chlorhexidine gluconate)
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class III · Low risk
Scrub-Stat 4
Subpotent drug
Class III · Low risk
Scrub Care Chlorhexidine Gluconate Solution
Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Class II · Moderate risk
Chlorhexidine gluconate 0.02% opthalmic solution packaged in an…
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
ChloraPrep With Tint
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Class II · Moderate risk
Chlorhexidine Opth Soln 0.02%
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
ChloraPrep One-Step
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
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