Hand Sanitizer Manufacturer Recalls Product for Manufacturing Deviations
EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: FDA Class II recalls with voluntary initiation and no reported illnesses or injuries are classified as Moderate per the severity rubric. The recall is for manufacturing process deviations (CGMP non-compliance) without known consumer harm.
Plain-English summary
EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) in 473 mL bottles due to manufacturing deviations that do not meet current good manufacturing practice (CGMP) standards. The voluntary recall was initiated on September 18, 2024, and classified as FDA Class II.
The recalled product is identified by lot number 042224-L1 with an expiration date of April 22, 2025 (NDC 76563-3010-1). A total of 120 bottles were distributed to one distributor in North Carolina. The manufacturer, EnviroServe Chemicals Inc., is located at 603 South Wilson Avenue, Dunn, NC 28334.
The recalled product
- Product
- EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
- Manufacturer
- EnviroServe Chemicals Inc.
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 120
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 (2)
- Lot #: 042224-L1
- Exp. Date 04/22/2025
Distribution
Distributed in 1 state:
Related recalls
Same hazard · manufacturing deviation
See all →- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
Similar recalls
- ModerateFDA Recalls Hand Sanitizer Gel Due to Manufacturing Deviations
FDA (Drugs) · 2020-09-02
- ModerateHand Sanitizer Recalled for Manufacturing Practice Deviations
FDA (Drugs) · 2023-01-25
- ModerateInopak Recalls Hand Sanitizer Due to Manufacturing Practice Deviations
FDA (Drugs) · 2019-06-05
- ModerateHand Sanitizer Recalled Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-01-25
- ModerateHand Sanitizer Recalled Over Manufacturing Quality Deviations
FDA (Drugs) · 2022-04-27
- SevereMEDICALLY MINDED Hand Sanitizer Gel Recalled for Manufacturing Deviations
FDA (Drugs) · 2021-09-08