Acne Medication Recalled

Defective containers have prompted Contract Pharmaceuticals Limited Canada to recall more than 57,000 bottles of clindamycin phosphate topical solution manufactured for Marlex Pharmaceuticals Inc., New Castle, Delaware, and Glasshouse Pharmaceuticals Limited Canada in Ontario. According to the March 13, 2024, US Food and Drug Administration (FDA) Enforcement Report, 12-month testing of samples revealed slow leakage of the solution from product containers.

The recall affects the following products, which were distributed throughout the United States and Puerto Rico:

• clindamycin phosphate topical solution 1%, 60-mL bottles (NDC 10135-0691-61), distributed by Marlex Pharmaceuticals, from lots 119466 (Exp. 4/25), 119467 (Exp. 4/25), 120351 (Exp. 8/25), and 121712 (Exp. 11/25); and
• clindamycin phosphate topical solution 1%, 60-mL bottles (NDC 71428-0003-60), distributed by Glasshouse Pharmaceuticals Limited Canada, from lot 119874 (Exp. 6/30/25).

Contract Pharmaceuticals Limited Canada voluntarily initiated the recall on February 20, 2024. The FDA designated the recall Class III on March 1, 2024, suggesting the use of the affected product is not likely to cause harm.

Clindamycin phosphate topical solution 1% is a prescription medication indicated for the treatment of acne vulgaris.