Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8...

FDA Drug Recall #D-0287-2022 — Class II — November 8, 2021

Recall Summary

Recall Number D-0287-2022
Classification Class II — Moderate risk
Date Initiated November 8, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries Inc
Location Northfield, IL
Product Type Drugs
Quantity 470,555 bottles

Product Description

Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.

Reason for Recall

Defective Container: Customer complaints for leaking bottles and dispensing issues.

Distribution Pattern

Nationwide in the USA, Canada, Hong Kong, and Peru

Lot / Code Information

Lot #: a) 32890, exp 04/2022; 33141, 33215, exp 10/2022; 33350, exp 12/2022; 33461, exp 03/2023; b) 32858, exp 02/2022; 32889, exp 03/2022; 32968, 32977, 32975, 32984, exp 06/2022; 33294, 33295, 33322, 33323, exp 12/2022; 33384, exp 01/2023; Lot 33620, exp 07/2023; c) 32728, exp 10/2021; 32859, 32889, exp 03/2022; 32985, 32988, 33004, exp 06/2022; 33339, exp 12/2022; 33501, exp 03/2023; 33502, exp 04/2023; 33621, 33622, exp 07/2023

Other Recalls from Medline Industries Inc

Recall # Classification Product Date
D-0624-2021 Class III READYPREP CHG, 2% Chlorhexidine Gluconate Cloth... May 14, 2021
D-0247-2019 Class II SparkleFresh Fluoride Toothpaste, Sodium Monofl... Sep 17, 2018
D-0546-2018 Class II PVP Scrub Solution, Povidone Iodine, 7.5% (equi... Feb 15, 2018
D-0271-2018 Class II Medline General Purpose Kit, Sterile, Single us... Sep 21, 2017
D-0277-2018 Class II Medline All Purpose Instrument Tray, Sterile. P... Sep 21, 2017

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.