4e Brands North America, Llc

Complete recall history across all FDA and CPSC categories — 10 total recalls

4e Brands North America, Llc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (10)

FDA drug safety enforcement actions by 4e Brands North America, Llc

Date Product Reason Class
Jul 11, 2020 blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... Chemical Contamination and Subpotent Drug: Product tested to contain methanol... Class I
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost ... CGMP Deviations: recalled because it was manufactured in the same facility as... Class II
Jul 11, 2020 blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/... CGMP Deviations: recalled because it was manufactured in the same facility as... Class II
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... Chemical Contamination and Subpotent Drug: Product tested to contain methanol... Class I
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... Chemical Contamination and Subpotent Drug: Product tested to contain methanol... Class I
Jul 11, 2020 blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), pac... CGMP Deviations: recalled because it was manufactured in the same facility as... Class II
Jul 11, 2020 ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Pack... CGMP Deviations: recalled because it was manufactured in the same facility as... Class II
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... CGMP Deviations: recalled because it was manufactured in the same facility as... Class II
Jul 11, 2020 ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packa... CGMP Deviations: recalled because it was manufactured in the same facility as... Class II
Jul 11, 2020 Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcoh... CGMP Deviations: recalled because it was manufactured in the same facility as... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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