Class II · Moderate risk
Mupirocin Ointment
cGMP deviations: Temperature abuse
Mupirocin Ointment
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDC
68462-0180-22
Compare with the code on your package — it is the most precise check available.
Drug: Mupirocin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Mupirocin NDC 68462-0180 |
20 mg/g | Ointment Topical |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-180-22
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0660-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mupirocin recalls
See all
Class II · Moderate risk
Bactroban Ointment
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Nasal
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2024 recalls
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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