Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
Affected NDC
51672-3007-01
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
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 |
|---|---|---|---|---|
| Hydrocortisone and Acetic Acid NDC 51672-3007 |
HYDROCORTISONE 10.4 mg/mL; ACETIC ACID 20.8 mg/mL | Solution Auricular (otic) |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- NDC code
- 51672-3007-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0633-2024 · 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 completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrocortisone recalls
See all
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
Essential Calming Skin Gel
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Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Other recalls by Taro Pharmaceuticals U.S.A., Inc.
All 2024 recalls
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
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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