Highest risk U.S. Food and Drug Administration

Assured, Blumen, Modesa Hand Sanitizer recall: Undeclared Methanol

Recall published 6+ years ago Last updated

Undeclared Methanol

Assured, Blumen, Modesa Prescription & OTC drugs — recalled prescription & otc drugsAssured, Blumen, Modesa Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Assured, Blumen, Modesa Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Assured, Blumen, Modesa Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 11, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Assured, Blumen, Modesa
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
639277490704, 639277490698, 814266023716, 814266023587, 814266023594, 814266023624, 814266023921, 814266024096, 814266023914, 814266024089, 814266023693, 814266023747, 814266023679, 814266023686, 032251499357

Products covered by this recall

Hand Sanitizer

What the company announced

San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer brands to the consumer level. These products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

RECALLED PRODUCTS

These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. This recall now includes all product manufactured by 4e within expiration, regardless of the size, UPC, or lot number. The recalled products are as follows:

  • Product(s): ASSURED ALOE HAND SANITIZER · Country of Origin: Mexico · Product Size: 8FL OZ/ 236 ML · Product Label: See Product Image Below · UPC Code: 639277490704
  • Product(s): ASSURED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 8FL OZ/ 236ML · Product Label: See Product Image Below · UPC Code: 639277490698
  • Product(s): ASSURED ALOE HAND SANITIZER · Country of Origin: Mexico · Product Size: 10FL OZ · Product Label: See Product Image Below · UPC Code: 639277490704
  • Product(s): ASSURED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 10FL OZ · Product Label: See Product Image Below · UPC Code: 639277490698
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 2 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023716
  • Product(s): BLUMEN ALOE ADVANCED HAND SANITIZER · Country of Origin: Mexico · Product Size: 3.4FL OZ · Product Label: See Product Image Below · UPC Code: 814266023587
  • Product(s): BLUMEN ADVANCED HAND SANITIZER · Country of Origin: Mexico · Product Size: 3.4FL OZ · Product Label: See Product Image Below · UPC Code: 814266023594
  • Product(s): BLUMEN ADVANCED HAND SANITIZER · Country of Origin: Mexico · Product Size: 7.5FLOZ / 221ML · Product Label: See Product Image Below · UPC Code: 814266023624
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 7.5 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023624
  • Product(s): BLUMEN ADVANCED HAND SANITIZER · Country of Origin: Mexico · Product Size: 7.5FLOZ / 221ML · Product Label: See Product Image Below · UPC Code: 814266023624
  • Product(s): BLUMEN ADVANCED HAND SANITIZER · Country of Origin: Mexico · Product Size: 15.2 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023921
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 17 FL OZ · Product Label: See Product Image Below · UPC Code: 814266024096
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 17 FL OZ · Product Label: See Product Image Below · UPC Code: 814266024096
  • Product(s): BLUMEN CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 18 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023914
  • Product(s): BLUMEN CLEAR TEA TREE HAND SANITIZER · Country of Origin: Mexico · Product Size: 18 FL OZ · Product Label: See Product Image Below · UPC Code: 814266024089
  • Product(s): BLUMEN ADVANCED HAND SANITIZER · Country of Origin: Mexico · Product Size: 33.8 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023693
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 33.8 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023693
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 33.8 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023693
  • Product(s): BLUMEN ADVANCED CLEAR TEA TREE HAND SANITIZER · Country of Origin: Mexico · Product Size: 33.8 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023747
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 70 FL OZ · Product Label: See Product Image Below · UPC Code: 814266023679
  • Product(s): BLUMEN ADVANCED CLEAR HAND SANITIZER · Country of Origin: Mexico · Product Size: 1.05 GAL · Product Label: See Product Image Below · UPC Code: 814266023686
  • Product(s): MODESA CLEAR GEL ANTIBACTERIAL · Country of Origin: Mexico · Product Size: 33.8 FL OZ · Product Label: See Product Image Below · UPC Code: 032251499357

The affected Hand Sanitizers are packaged in clear plastic bottles with variation of tops, including blue, white, or clear pumps or caps. The product labels are displayed in the chart above and also included in this press release under images.

The product was distributed nationwide in the United States through retailers and distributors.

4e Brands North America is notifying its distributors and retailers by recall letter and consumers via this press release. 4e Brands North America is arranging for the return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/ selling the hand sanitizer and return it to the place of purchase.

Consumers with questions regarding this recall can contact 4e Brands North America LLC at:

Toll Free: 888-843-0254 Mon-Fri 8am – 8 PM Eastern

FAX: 888-214-7430

Event: 8797

Website: https://www.blumensanitizerrecall.expertinquiry.com/

Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDA updates on hand sanitizers consumers should not use

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

How this recall developed

The company posted 2 announcements about this recall on fda.gov. They are kept together on this page: the products, codes and places listed above are combined from all of them, and the announcement text comes from the most recent English version.

  1. July 11, 2020 — First announcement. 4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol) Read it on fda.gov
  2. July 24, 2020 — Recall expanded. 4e Brands North America Issues Expanded Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol) Read it on fda.gov

Check your product

The notice names 57 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 639277490704
  • 639277490698
  • 814266023716
  • 814266023587
  • 814266023594
  • 814266023624
  • 814266023921
  • 814266024096
  • 814266023914
  • 814266024089
  • 814266023693
  • 814266023747
  • 814266023679
  • 814266023686
  • 032251499357

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2213
  • 2219
  • 2220
  • 2221
  • 2223
  • 2225
  • 2252
  • 2255
  • 2226
  • 2227
  • 2254
  • 2467
  • 2369
  • 2440
  • 2368
  • 2499
  • 2439
  • 2576
  • 2680
  • 2744

Model or item number

On the rating label, the box or the instruction sheet.

  • 236 ML
  • 236ML
  • 221ML

Package size

Match the net weight or the piece count on the front of the pack.

  • 8 FL OZ
  • 236 ML
  • 10 FL OZ
  • 2 FL OZ
  • 3.4 FL OZ
  • 7.5 FLOZ
  • 221 ML
  • 7.5 FL OZ
  • 15.2 FL OZ
  • 17 FL OZ
  • 18 FL OZ
  • 33.8 FL OZ
  • 70 FL OZ
  • 1 L
  • 532 ml
  • 60 ml
  • 503 ml
  • 4 L
  • 100 ml

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Assured, Blumen, Modesa — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: 4e Brands North America is notifying its distributors and retailers by recall letter and consumers via this press release. 4e Brands North America is arranging for the return and refund of all recalled products.

Company contact: 4e Brands North America — Consumers: 4e Brands North America, 888-843-0254

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Assured, Blumen, Modesa prescription & otc drugs recalled?

Undeclared Methanol Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 639277490704, 639277490698, 814266023716; lot code 2213, 2219, 2220; model number 236 ML, 236ML, 221ML. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: 4e Brands North America is notifying its distributors and retailers by recall letter and consumers via this press release. 4e Brands North America is arranging for the return and refund of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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