CLASS II Drug recall · Reported 29 Jun 2022 · FDA Enforcement Report

70% Isopropyl Alcohol First aid antiseptic recalled by Vi-Jon

Vi-Jon is recalling 70% Isopropyl Alcohol First aid antiseptic, distributed nationwide in the US. The recall was initiated on 15 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots #s: 0517418, Exp. 12/2022; 0506632, 0519195, 0522494, Exp. 01/2023; 0525627, 0525629, 0526051, 0526052, 0527664, 0527665, Exp. 03/2023; 0531133, 0531134, Exp. 04/2023; 0533153, 0534050, Exp. 05/2023; 0534585, 0534587, 0536089, Exp. 06/2023; 0538694, 0541334, Exp. 07/2023; 0539877, 0542355, Exp. 08/2023; 0545225, 0547054, 0547055, 0547131, Exp. 09/2023; 0547130, 0551014, 0551015, 0552608, Exp. 10/2023; 0552609, 0552610, 0553905, Exp. 11/2023; 0556144, 0557513, Exp. 12/2023; 0559594, 0559602, 0559603, Exp. 01/2024; 0551013, 0559596, 0559604, 0559605, 0561393, 0561395, Exp. 02/2024; 0556143, 0561396, 0561549, Exp. 03/2024; 0565877, Exp. 04/2024
NDC53329-798
Quantity recalled3,157,620 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-1151-2022
FDA event ID
90453
Recalling firm
Vi-Jon, Smyrna, TN
Manufacturer
Medline Industries, LP
Classification
Class II
Status
Terminated
Recall initiated
15 Jun 2022
FDA classified
21 Jun 2022
Reported
29 Jun 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

15 Jun 2022Recall initiated by company
21 Jun 2022Classified by FDA+6 days
29 Jun 2022Published in enforcement report+8 days

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

Reason for recall

Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline Industries, Inc., Mundelein, IL 60060 USA, NDC: 53329-798-04, UPC (01) 10888277362291.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.

Which lots are affected?

Lots #s: 0517418, Exp. 12/2022; 0506632, 0519195, 0522494, Exp. 01/2023; 0525627, 0525629, 0526051, 0526052, 0527664, 0527665, Exp. 03/2023; 0531133, 0531134, Exp. 04/2023; 0533153, 0534050, Exp. 05/2023; 0534585, 0534587, 0536089, Exp. 06/2023; 0538694, 0541334, Exp. 07/2023; 0539877, 0542355, Exp. 08/2023; 0545225, 0547054, 0547055, 0547131, Exp. 09/2023; 0547130, 0551014, 0551015, 0552608, Exp. 10/2023; 0552609, 0552610, 0553905, Exp. 11/2023; 0556144, 0557513, Exp. 12/2023; 0559594, 0559602, 0559603, Exp. 01/2024; 0551013, 0559596, 0559604, 0559605, 0561393, 0561395, Exp. 02/2024; 0556143, 0561396, 0561549, Exp. 03/2024; 0565877, Exp. 04/2024

Where was it sold?

Nationwide in the USA

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.

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