Clindamycin Phosphate recall
FDA recall D-0364-2024 · initiated Feb 20, 2024
Contract Pharmaceuticals Limited Canada recalled Clindamycin Phosphate in Feb 2024 — an FDA Class III recall (D-0364-2024) because Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
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.
Quantity recalled: 45,875 bottles
Details
- Product
- Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
- Recalling company
- Contract Pharmaceuticals Limited Canada
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Initiated
- Feb 20, 2024
- FDA report date
- Mar 13, 2024
Frequently asked
- Was Clindamycin Phosphate recalled?
- Contract Pharmaceuticals Limited Canada recalled Clindamycin Phosphate in Feb 2024 — an FDA Class III recall (D-0364-2024) because Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Clindamycin Phosphate recalled?
- Per the FDA enforcement record, the reason for recall D-0364-2024 was: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Is a recalled Clindamycin Phosphate 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 are affected?
- Distributed: Nationwide in the U.S. and Puerto Rico. The recall covers these lots — Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025. 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-0364-2024.