CLASS II Drug recall · Reported 9 Sep 2020 · FDA Enforcement Report

UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol) recalled

Santa Cruz Biotechnology is recalling UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), distributed nationwide in the US. The recall was initiated on 7 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: BF12530, Exp 05/11/2022
Quantity recalled14,238 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1557-2020
FDA event ID
86197
Recalling firm
Santa Cruz Biotechnology, Dallas, TX
Classification
Class II
Status
Terminated
Recall initiated
7 Aug 2020
FDA classified
28 Aug 2020
Reported
9 Sep 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

7 Aug 2020Recall initiated by company
28 Aug 2020Classified by FDA+21 days
9 Sep 2020Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent drug

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220

Where it was distributed

U.S.A. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Subpotent drug

Which lots are affected?

Lot#: BF12530, Exp 05/11/2022

Where was it sold?

U.S.A. Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.