Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Clindamycin Phosphate USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
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
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Affected NDC
51672-4081-04
Compare with the code on your package — it is the most precise check available.
Drug: Clindamycin Category: Antibiotic
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 |
|---|---|---|---|---|
| Clindamycin Phosphate NDC 51672-4081 |
10 mg/mL | Solution Topical |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 51672-4081-4
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0257-2026 · 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.
Other Clindamycin recalls
See all
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Phosphate in 0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Other recalls by Sun Pharmaceutical Industries INC
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Nystatin Cream
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Class II · Moderate risk
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CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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