Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60

Recall Insight

This FDA Drug action (record #D-1451-2014) was formally reported on July 30, 2014, with the manufacturer initiating the action on September 27, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Shamrock Medical Solutions Group LLC is listed as the recalling firm, operating out of Lewis Center, OH. Federal records indicate 99/240 mg softgel caps units are affected.

The documented reason for this recall is: Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg Distribution data in the federal record shows the product reached: Product was shipped to the following states: CO, MA, OH, TX & WY.. 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 12 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.