CLASS II Drug recall · Reported 2 Oct 2024 · FDA Enforcement Report

Mupirocin Ointment recalled by Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Inc., USA is recalling Mupirocin Ointment, USP, 2%, distributed nationwide in the US. The recall was initiated on 30 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 19223615, 19223537, 19223544,19223568, 19223593,19223641, Exp. Date 08/2024; 19224055,19224281, 19224307, 19224321, 19224341, 19224467, Exp. Date 09/2024; 19224525, 19224542, 19224560,19224580, Exp. Date 10/2024; 19224990, 19224998, 19225014, 19225033, 19225293, 19225304, 19225320, 19225349, 19225367, 19225379, 19225401, Exp. Date 11/2024; 19230115, 19230123, 19230132, 19230137, 19230167, 19230170, Exp. Date 12/2024; 19230572, 19230607, 19230614, 19230628, 19230631, Exp. Date 1/2025; 19230874, 19230925,19230941, 19230957, 19230976,19231232, 19231238, 19231282,19231285, Exp. Date 02/2025.

NDC68462-180

Quantity recalled2,031,480 ointments

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-0660-2024
FDA event ID: 95279
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Brand: Mupirocin
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Classification: Class II
Status: Completed
Recall initiated: 30 Aug 2024
FDA classified: 20 Sep 2024
Reported: 2 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

30 Aug 2024	Recall initiated by company
20 Sep 2024	Classified by FDA	+21 days
2 Oct 2024	Published 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

Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.

Where it was distributed

Product was distributed nationwide within the United States.

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug

Which lots are affected?

Lot #: 19223615, 19223537, 19223544,19223568, 19223593,19223641, Exp. Date 08/2024; 19224055,19224281, 19224307, 19224321, 19224341, 19224467, Exp. Date 09/2024; 19224525, 19224542, 19224560,19224580, Exp. Date 10/2024; 19224990, 19224998, 19225014, 19225033, 19225293, 19225304, 19225320, 19225349, 19225367, 19225379, 19225401, Exp. Date 11/2024; 19230115, 19230123, 19230132, 19230137, 19230167, 19230170, Exp. Date 12/2024; 19230572, 19230607, 19230614, 19230628, 19230631, Exp. Date 1/2025; 19230874, 19230925,19230941, 19230957, 19230976,19231232, 19231238, 19231282,19231285, Exp. Date 02/2025.

Where was it sold?

Product was distributed nationwide within the United States.

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.

More recalls from Glenmark Pharmaceuticals Inc., USA

All 141

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Drug	CLASS II	Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide

Other Mupirocin recalls

All 3

Reported	Class	Recall	Company	Reason	Where
15 Jun 2022Drug	CLASS II	Mupirocin Ointment, USP 2% tube recalled by Mckesson Medical-SurgicalMupirocin	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
2 Sep 2015Drug	CLASS II	Mupirocin Calcium Cream, 2%, a) tube recalled by GlaxoSmithKline	GlaxoSmithKline	Other	Nationwide