Class II · Moderate risk
Betamethasone Dipropionate Ointment USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Clotrimazole and Betamethasone Dipropionate Cream USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
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
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
Affected NDC
51672-4048-01
Compare with the code on your package — it is the most precise check available.
Drug: Betamethasone
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 |
|---|---|---|---|---|
| Clotrimazole and Betamethasone Dipropionate NDC 51672-4048 |
CLOTRIMAZOLE 10 mg/g; BETAMETHASONE DIPROPIONATE .5 mg/g | Cream Topical |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- NDC code
- 51672-4048-1
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0727-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Betamethasone recalls
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Class II · Moderate risk
Celestone Soluspan
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betamethasone Dipropionate Cream USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Other recalls by Taro Pharmaceuticals U.S.A., Inc.
All 2022 recalls
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
Class II · Moderate risk
Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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