CLASS III Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Clotrimazole and Betamethasone Dipropionate Cream recalled
Glenmark Pharmaceuticals Inc., USA is recalling Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% tubes, distributed nationwide in the US. The recall was initiated on 7 Aug 2019 and the FDA has classified it as Class III.
Check your package
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-1743-2019
- FDA event ID
- 83526
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc. USA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Aug 2019
- FDA classified
- 15 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 Aug 2019 | Recall initiated by company | |
| 15 Aug 2019 | Classified by FDA | +8 days |
| 21 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Complaints received of liquidy texture.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17
Where it was distributed
Nationwide with the United States
Questions about this recall
Why was it recalled?
Temperature Abuse: Complaints received of liquidy texture.
Which lots are affected?
Lot #: 05180734, Exp. 03/2020
Where was it sold?
Nationwide with 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
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|---|---|---|---|---|---|
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| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
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| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Clotrimazole recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Globe Clotrimazole Cream USP, 1 % Antifungal Cream recalledClotrimazole | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Globe Clotrimazole Cream, USP, 1 % recalled by Blossom PharmaceuticalsClotrimazole | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Equate Athlete's Foot, Clotrimazole recalledClotrimazole | Taro Pharmaceuticals U | Potency & Assay | Nationwide |