openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Code information
Lot # 23101201 exp 09/2026, 24080801 exp 07/2027, and 25020701 exp 01/2028
Distribution pattern
The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.
drug · product 2 of 2
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Code information
Lot # 23101202 exp 09/2026, 24080802 exp 07/2027, and 25020702 exp 01/2028
Distribution pattern
The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.
