READYPREP CHG Chlorhexidine Gluconate Cloth recalled for superpotency
Medline Industries is recalling READYPREP CHG 2% Chlorhexidine Gluconate Cloth because the product contains higher-than-specified levels of the active ingredient.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall. The hazard is superpotency (above-specification active ingredient content) with no reported illnesses or injuries mentioned in the source. This is a precautionary recall and falls under the Moderate category per the rubric.
Plain-English summary
Medline Industries Inc is recalling READYPREP CHG, a non-sterile topical antiseptic cloth containing 2% Chlorhexidine Gluconate. The product is being recalled because it is above specification for its active ingredient, meaning it contains more chlorhexidine gluconate than intended.
The recalled product consists of disposable cloths sold in packs of 2 (9x10.5 inches). The affected lots are: Lot #19EEA027 (Exp May 2021), Lot #19GEA049 (Exp August 2021), and Lot #19HEA044 (Exp September 2021). A total of 231,936 packs were distributed nationwide in the USA and Israel.
Consumers and healthcare facilities should stop using the recalled product. Persons with questions or who believe they have been affected by this recall should contact Medline Industries Inc or speak with a healthcare professional.
The recalled product
- Product
- READYPREP CHG (CHLORHEXIDINE GLUCONATE 2%)
- Brand
- READYPREP CHG
- Manufacturer
- Medline Industries Inc
- Affected units
- 231,936
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #:: 19EEA027
- Exp May 2021
- 19GEA049
- Exp August 2021
- 19HEA044
- Exp Sept 2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · superpotency
See all →- CriticalVitruvias Recalls Superpotent Thyroid Tablets Nationwide
FDA (Drugs) · 2026-09-23
- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
Similar recalls
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to CGMP Deviations
FDA (Drugs) · 2016-12-28
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- SevereMedline recalls flushable personal cleaning cloths due to microbial contamination
FDA (Drugs) · 2018-06-20
- ModerateSage Products Recalls Chlorhexidine Skin and Oral Care Kits
FDA (Drugs) · 2018-02-21
- ModerateAkorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Crystallization
FDA (Drugs) · 2017-08-23
- ModerateAkorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity
FDA (Drugs) · 2016-06-01