Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 51672-3007-01 recalled?

Hydrocortisone and Acetic Acid · 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE

Yes — this exact package was recalled

2 FDA recalls name the code 51672-3007-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Hydrocortisone and Acetic Acid
Strength
HYDROCORTISONE 10.4 mg/mL; ACETIC ACID 20.8 mg/mL
Form
Solution · Auricular (otic)
Labeler
Sun Pharmaceutical Industries, Inc.
Type
Human Prescription Drug
Product code
51672-3007

Recalls naming this package

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.

Completed Impurity / degradation Taro Pharmaceuticals U.S.A., Inc. NDC 51672-3007-01 D-0633-2024
Class III · Low risk

Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP

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.

Terminated Impurity / degradation Taro Pharmaceuticals Inc. NDC 51672-3007-1 D-0089-2024

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler