FDA Warning Letters

Rxgoodusa Warning Letter Unapproved Opioids Benzodiazepines Internet Sales

FDA issued a Warning Letter to Rxgoodusa (www.rxgoodusa.com) for introducing unapproved new drugs and misbranded drugs into interstate commerce in violation of the FD&C Act. The violations involve opioids and benzodiazepines sold online without required FDA approval. This is the company's second Warning Letter, having received a prior letter in August 2025 while operating under www.usaquickmeds.com. FDA requests immediate cessation of sales of all unapproved and misbranded drugs.

Beauty of Aztlan LLC, Unapproved Drug Violations

FDA issued a Warning Letter to Beauty of Aztlan LLC for introducing unapproved new drugs into interstate commerce via their website www.beautyofaztlan.squarespace.com. The violations involve injectable botulinum toxin products marketed as "Botulax 100units" and "Innotox 50units" without FDA-approved applications, in violation of sections 301(d) and 505(a) of the FD&C Act. FDA requests the company immediately cease offering any unapproved and misbranded drugs for sale to U.S. consumers.

Online Rx Medz Warning Letter - Unapproved Opioids, Benzodiazepines, and Stimulants

FDA issued a Warning Letter to Online Rx Medz (www.onlinerxmedz.com) for introducing unapproved and misbranded drugs into interstate commerce in violation of the FD&C Act. The observed violations involve opioids, benzodiazepines, and Schedule II stimulants. FDA requests the company immediately cease offering any unapproved and misbranded drugs for sale to U.S. consumers.

Chemco Corp Warning Letter - CGMP and Drug Violations

The FDA issued Warning Letter 320-26-60 to Chemco Corporation on April 7, 2026, citing significant violations found during an August 11-22, 2025 inspection of their drug manufacturing facility in Miami Lakes, FL (FEI 1042599). Investigators identified CGMP violations including inadequate equipment cleaning and lack of cleaning validation studies for non-dedicated equipment. The firm also distributed unapproved new drugs and misbranded drug products including PRO Nail FUNGUS KILLER and multiple Eternal Spirit Beauty and SPA REDI products.

Purolea Cosmetics Lab CGMP Violations Warning Letter 320-26-58

FDA issued Warning Letter 320-26-58 to Purolea Cosmetics Lab (FEI 3011669383) in Livonia, MI, citing CGMP violations and insanitary conditions found during an October 2025 inspection. Investigators observed insects, filth, leaves, and clutter in manufacturing areas, and inadequate separation from outside contamination. The firm failed to conduct required microbiological testing on drug batches before release. Two products, Dermveda Extra Strength Shingles Relief and Dermveda Extra Strength Ultra Genital Herpes Relief, are flagged as unapproved new drugs intended to treat serious conditions.

Dry Springs Pharmacy Warning Letter - Unapproved Opioids, Benzodiazepines, and Schedule II Stimulants

FDA issued a warning letter to Dry Springs Pharmacy (dryspringspharmacy.net) for introducing unapproved and misbranded opioids, benzodiazepines, and Schedule II stimulants into interstate commerce in violation of the FD&C Act. The agency found the website markets drugs that circumvent regulatory safeguards, posing significant public health risks given the ongoing opioid epidemic and benzodiazepine nonmedical use crisis. FDA has requested the pharmacy immediately cease offering these unapproved drugs for sale to U.S. consumers.

Smart Vending Services LLC - Nicotine Pouch Marketing Violation Warning

The FDA Center for Tobacco Products issued a Warning Letter to Smart Vending Services, LLC (Henderson, NV) for marketing new nicotine pouch products, including HYPPE Wintergreen 8 mg, without required premarket authorization under section 910 of the FD&C Act. FDA determined the products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) for failure to provide required premarket reports. The firm is required to ensure all tobacco products it sells or distributes have proper FDA marketing authorization or face enforcement action.

FormPour Warning Letter - Unapproved New Drug Sales via eBay

FDA issued a warning letter to FormPour (Shuja Arshad) for selling an unapproved new drug product, the 'SMGT-GLT-1 Nano Microneedle Patch,' on eBay. The product makes unapproved claims for treating Type 2 diabetes, weight loss, and cardiovascular protection, violating sections 301(d) and 505(a) of the FD&C Act. The recipient has 15 working days to respond with corrective actions or face seizure and injunction.

Pure Indulgence Aesthetics - DSCSA Trading Partner and Product Tracing Violations

FDA issued a Warning Letter to Pure Indulgence Aesthetics, a medical spa in Southlake, TX, identifying DSCSA violations under Section 582(d) of the FD&C Act. Investigators found the firm dispensed significantly more Botox units than documented in purchase records from AbbVie, indicating potential sourcing from unauthorized trading partners. The firm must respond with corrective actions within the specified timeframe.

Pink Pony Peptides - Unapproved New Drugs Warning

FDA issued a Warning Letter to Lovega LLC dba Pink Pony Peptides for marketing and selling unapproved new drugs, including peptide products GLP-2 TZ, GLP-3 RT, and Bacteriostatic Water. The products were found to be marketed with therapeutic claims despite labeling stating 'not for human consumption.' FDA determined the products meet the definition of new drugs under the FD&C Act and require approved applications before sale.