Contract Pharmaceuticals Limited Canada recalls Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex
Marlex recalls 1% Clindamycin Phosphate Topical Solution due to potential container leakage affecting stability. Discard or return affected lots before expiration.
Lower-risk recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Contact the company & request your remedy
What happened, in plain English
Marlex is recalling 1% Clindamycin Phosphate Topical Solution (Rx only) because the container may leak over time, risking product instability. This could lead to ineffective treatment if used after the expiration date. Read more at govinfonow.com/recall/32802-marlex-clindamycin-phosphate-topical-solution-recall-container-leakage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32802-marlex-clindamycin-phosphate-topical-solution-recall-container-leakage-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0364-2024
Cite this page
“Marlex Clindamycin Phosphate Topical Solution Recall: Container Leakage Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32802-marlex-clindamycin-phosphate-topical-solution-recall-container-leakage-risk. Based on FDA recall #D-0364-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0364-2024%22&limit=1).
Why it’s dangerous
The container may leak slowly over time, especially after 12 months of storage. This leakage could cause the medication to become unstable, potentially reducing its effectiveness before the expiration date.
Who’s affected
Prescription users of the 1% Clindamycin Phosphate Topical Solution who received the recalled lots (NDC 10135-0691-61) from Marlex. Patients with skin infections requiring this medication are most at risk.
How to tell if you have this one
Check the product label for the NDC code 10135-0691-61. The recalled lots have specific expiration dates: 04/2025, 08/2025, and 11/2025. The product is only available by prescription.
- Brand
Marlex- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Ongoing- Distribution
Nationwide in the U.S. and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0364-2024 | 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; Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025 | 45,875 bottles |
| D-0365-2024 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60; Lot #: 119874; Exp 06/30/2025 | 11,750 bottles |
What to do — step by step
Check Product Label
Look for the NDC code 10135-0691-61 on the container.
Discard Recalled Product
If you have the recalled lots, discard them immediately to avoid potential instability.
Questions people ask
Is this product safe to use?
The product may become unstable due to slow leakage, so it is not recommended for use after the expiration date.
How do I know if I have the recalled product?
Check the product label for the NDC code 10135-0691-61 and the specific expiration dates: 04/2025, 08/2025, or 11/2025.
What should I do if I have the recalled product?
Discard the product immediately to avoid potential instability.
Contact Marlex
We’ve drafted a message you can send Marlex to request your refund or repair — edit it as you like.
Subject: Recall D-0364-2024 — Marlex Marlex Hello, I own a Marlex that is covered by recall D-0364-2024 from Marlex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0364-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0364-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.