Overview
- Akkarco LLC recalled Ashfiat Alharamain Energy Support lot ENCOT24, expiring October 2028, after FDA testing detected tadalafil not listed on the label.
- The product was sold nationwide online, including Amazon, and the company says it has halted non‑prescription sales and is contacting purchasers as listings are removed.
- FDA classified the item as an unapproved new drug because its safety and efficacy have not been established.
- No confirmed adverse events have been reported to date, and consumers are urged to stop use, consult a healthcare provider if concerned, and report issues via FDA MedWatch.
- Health officials warn tadalafil can cause dangerous blood‑pressure drops and drug interactions, and similar undisclosed pharmaceuticals have been documented previously in sexual‑enhancement supplements.