FDA WARNING_LETTER - Citra100mg - March 01, 2026

The FDA issued a Warning Letter to Citra100mg on March 4, 2026, following a recent review of their website, www.citra100mg.com. The primary violations identified involve the unlawful sale of unapproved and misbranded opioid drugs to U.S. consumers over the Internet, specifically various tramadol formulations marketed as “Citra 100mg,” “Clovidol 100mg,” and others. The agency noted that these products are unapproved new drugs lacking FDA clearance for safety and effectiveness, violating sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Furthermore, the drugs are considered misbranded under the FD&C Act because they are prescription-only medications sold without requiring a valid prescription and do not bear adequate directions for safe use by a layperson. The FDA highlighted the inherent risks of such sales, especially concerning the ongoing opioid epidemic, warning that unapproved drugs could be counterfeit, contaminated, or contain incorrect ingredients.

Citra100mg is required to immediately cease offering all unapproved and misbranded drugs for sale to U.S. consumers. The company must provide a written response to the FDA within 15 working days, detailing the specific corrective actions taken to address all violations and prevent their recurrence. Failure to comply may result in further legal action, including seizure or injunction.