Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP (Hydrocortisone and Acetic Acid)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity 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% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
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 Inc.
- NDC code
- 51672-3007-1
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0089-2024 · 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 terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrocortisone recalls
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Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
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Class III · Low risk
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Class III · Low risk
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Other recalls by Taro Pharmaceuticals Inc.
All 2023 recalls
Class II · Moderate risk
Desoximetasone Cream USP
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class II · Moderate risk
Desoximetasone Cream USP
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class III · Low risk
Topicort (desoximetasone)
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
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