Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.

Recall Insight

This FDA Drug action (record #D-0785-2016) was formally reported on April 6, 2016, with the manufacturer initiating the action on July 16, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Safecor Health, LLC is listed as the recalling firm, operating out of Woburn, MA. Federal records indicate 23 cups units are affected.

The documented reason for this recall is: Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml. Distribution data in the federal record shows the product reached: NY. 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 10 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.