Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufacture...

FDA Drug Recall #D-0458-2025 — Class II — May 23, 2025

Recall Summary

Recall Number D-0458-2025
Classification Class II — Moderate risk
Date Initiated May 23, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Consumer Product Partners, LLC
Location Smyrna, TN
Product Type Drugs
Quantity 125,040 bottles

Product Description

Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5

Reason for Recall

Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16

Other Recalls from Consumer Product Partners, LLC

Recall # Classification Product Date
D-0661-2025 Class III TopCare Health 70% Isopropyl Alcohol, NET WT 5.... Aug 25, 2025
D-0660-2025 Class III Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (15... Aug 25, 2025
D-0302-2025 Class II [CORRECT FRONT PANEL] Hydrogen Peroxide Topical... Mar 7, 2025
D-0560-2024 Class II Petroleum Jelly, White Petrolatum USP, NET WT 1... May 28, 2024

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.