CLASS III ONGOING Drug recall · Reported 21 Jan 2026 · FDA Enforcement Report
Clindamycin Phosphate USP, 1% (10 mg/mL) recalled
Sun Pharmaceutical Industries is recalling Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution per applicator, distributed nationwide in the US. The recall was initiated on 26 Nov 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0257-2026
- FDA event ID
- 98062
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Nov 2025
- FDA classified
- 14 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 26 Nov 2025 | Recall initiated by company | |
| 14 Jan 2026 | Classified by FDA | +49 days |
| 21 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution per applicator recalled?
Yes. Sun Pharmaceutical Industries recalled Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution per applicator on 26 Nov 2025. The recall is Class III and its status is Ongoing. Recall number D-0257-2026.
Why was it recalled?
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Which lots are affected?
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sun Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | Sun Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Clindamycin Phosphate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Phosphate in 9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |