Clindamycin Phosphate Topical Solution recalled for defective container leakage
Contract Pharmaceuticals Limited Canada is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak slowly. The product was distributed nationwide in the U.S. and Puerto Rico.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III classification with no reported illnesses or injuries. The defect is a container integrity issue involving slow leakage, which is a quality and product-viability concern but not an active safety hazard.
Plain-English summary
Contract Pharmaceuticals Limited Canada, manufacturing for Marlex Pharmaceuticals, Inc., is recalling 45,875 bottles of Clindamycin Phosphate Topical Solution USP, 1%, 60 mL (NDC 10135-0691-61).
The containers for this product are out of specification for weight due to slow leakage observed at the 12-month stability timepoint. This may affect the product's integrity and potency.
The affected product was distributed nationwide in the United States and Puerto Rico under lot numbers 119466 and 119467 (expiration 04/2025), 120351 (expiration 08/2025), and 121712 (expiration 11/2025).
Patients and healthcare providers with this product should discontinue use and contact their pharmacy or healthcare provider for guidance. Healthcare facilities should quarantine affected inventory. The FDA and the recalling firm are available for additional information.
The recalled product
- 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
- Manufacturer
- Contract Pharmaceuticals Limited Canada
- Category
- Drug — Topical
- Hazard
- container-defect
- product-leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 119466
- 119467 Exp 04/2025
- 120351 Exp 08/2025
- 121712 Exp 11/2025
Distribution
Distributed nationwide across the United States.
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