Clindamycin Phosphate USP recall
FDA recall D-0257-2026 · initiated Nov 26, 2025
SUN PHARMACEUTICAL INDUSTRIES INC recalled Clindamycin Phosphate USP in Nov 2025 — an FDA Class III recall (D-0257-2026) because Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- 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
- Recalling company
- Sun Pharm Industries
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Nov 26, 2025
- FDA report date
- Jan 21, 2026
Frequently asked
- Was Clindamycin Phosphate USP recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Clindamycin Phosphate USP in Nov 2025 — an FDA Class III recall (D-0257-2026) because Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Clindamycin Phosphate USP recalled?
- Per the FDA enforcement record, the reason for recall D-0257-2026 was: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
- Is a recalled Clindamycin Phosphate USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clindamycin Phosphate USP are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0257-2026.