Mupirocin Antibiotic Ointment Recalled Nationwide Due to Subpotency
Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II voluntary recall of a subpotent drug. While no illnesses or injuries have been reported, subpotency of an antibiotic represents a risk-of-harm product: affected patients may use the product believing it will treat their infection effectively, but the reduced efficacy could result in treatment failure and potential complications from untreated infection.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Mupirocin Ointment, USP 2%, 22-gram tubes nationwide due to subpotency. Mupirocin is a topical antibiotic used to treat skin infections; subpotent lots contain less active ingredient than specified and may not be effective.
The recall affects approximately 2,031,480 units distributed nationwide. Affected lot numbers range from 19223615 to 19231285, with expiration dates from August 2024 through February 2025. The product (NDC 68462-180-22) was manufactured by Glenmark Pharmaceuticals Ltd. in India and distributed by Glenmark Pharmaceuticals Inc. in Mahwah, New Jersey.
Patients should not use affected lots. Those with affected product should contact their prescriber or pharmacist for guidance on alternative or replacement product. The recall was initiated voluntarily by the manufacturer on August 30, 2024.
The recalled product
- Product
- MUPIROCIN (MUPIROCIN)
- Brand
- MUPIROCIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical Antibiotic
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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