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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Fisher Scientific Hand Sanitizer Recalled for CGMP Deviations

Agency Publication Date: January 18, 2023
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Summary

Fisher Scientific Co., LLC has issued a voluntary recall for Fisher Scientific Hand Sanitizer (75% isopropyl alcohol) distributed after March 31, 2022. The recall affects 1,183 units, including 500 mL bottles, 4 L bottles, and cases. These products were manufactured and distributed after the FDA's temporary pandemic-era approval for hand sanitizer production had expired, meaning they may not have been produced under standard quality manufacturing practices.

Risk

These products were distributed without adherence to Current Good Manufacturing Practice (CGMP) guidelines established after the expiration of temporary FDA pandemic guidance. Failure to meet these quality standards can lead to products that do not meet safety or effectiveness specifications, potentially increasing the risk of skin irritation or ineffective germ-killing.

What You Should Do

  1. This recall affects Fisher Scientific Hand Sanitizer (Isopropyl Alcohol, 75%) packaged in 500 mL and 4 L bottles, as well as cases containing six 500 mL bottles.
  2. Check the lot number printed on the label of your bottle or case. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Fisher Scientific Co., LLC directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Hand Sanitizer (Isopropyl Alcohol), 75% v/v (500 mL)
Variants: 500 mL bottle, 6 x 500 mL bottles per case
Model:
HSANI500ML
Lot Numbers:
202160
202162
202324
202368
202369
202593
202594
202835
202862
202863
202865
202836
202864
203061
203098
203099
203100
203101
203102
203236
203237
203239
203337
203338
203335
203336

Recall #: D-0163-2023; Quantity: 1077 bottles and 52 cases

Product: Hand Sanitizer (Isopropyl Alcohol), 75% Topical Solution (4 L)
Variants: 4 L bottles
Model:
HSANI4LI
Lot Numbers:
202161
202322
202323
202794
202858
203188
203238
203240
203722
203723
203724
203725
204852

Recall #: D-0164-2023; Quantity: 106 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91427
Status: Active
Manufacturer: Fisher Scientific Co., LLC
Manufactured In: United States, Belgium
Units Affected: 2 products (a) 1077 bottles, b) 52 cases; 106 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.