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

Recall Insight

This FDA Drug action (record #D-0364-2024) was formally reported on March 13, 2024, with the manufacturer initiating the action on February 20, 2024. It is classified under Low severity (Class III), with a current status of Ongoing. Contract Pharmaceuticals Limited Canada is listed as the recalling firm, operating out of Mississauga. Federal records indicate 45,875 bottles units are affected.

The documented reason for this recall is: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. Distribution data in the federal record shows the product reached: Nationwide in the U.S. and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.