Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37

Recall Insight

This FDA Drug action (record #D-0514-2019) was formally reported on February 27, 2019, with the manufacturer initiating the action on February 7, 2019. It is classified under Low severity (Class III), with a current status of Terminated. ACP Nimble Buyer, Inc. is listed as the recalling firm, operating out of South Plainfield, NJ. Federal records indicate 58,176 units units are affected.

The documented reason for this recall is: Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. Distribution data in the federal record shows the product reached: Nationwide within the United States. 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 4 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 7 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.