FDA Drug Recalls (Class I)

Green Lumber Holdings Recalls Natural Fuel For Men Capsules

Green Lumber Holdings, LLC initiated a voluntary Class I recall of its Natural Fuel For Men capsules after FDA analysis found the product contained tadalafil, an unapproved drug ingredient. The recall affects one lot (LOT308EXP03/28) distributed nationwide in 2, 4, 10, and 30-count blister packs. The firm initiated the recall on August 28, 2025; FDA classified it as Class I on February 10, 2026.

Class I Recall: UDENYCA (pegfilgrastim-cbqv) Temperature Abuse - Lot 2199821

FDA has classified a Class I recall of UDENYCA (pegfilgrastim-cbqv) injection 6mg/0.6mL prefilled syringes distributed by McKesson. The recall affects 116 cartons of Lot 2199821 (expires 05/31/2027) with 116 specific serial numbers due to temperature abuse. The affected product was stored at controlled room temperature instead of the required refrigerated environment. FDA classified this as a Class I recall on 2026-02-26. The recall was initiated by the firm on 2026-01-16 and is ongoing.

SILINTAN 25 Pills Class I Recall Issued by FDA

FDA classified a Class I drug recall for SILINTAN 25 pills, 123Herbals LLC, following analysis revealing the presence of undeclared meloxicam. The firm voluntarily initiated the recall on October 20, 2025, after FDA determined the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). All lots within expiry are affected, with distribution nationwide in the United States.

Mojo Max Fusion XXX Recall - Undeclared Sildenafil and Tadalafil

FDA has classified Class I recall D-0396-2026 for Mojo Max Fusion XXX (500 mg capsules) distributed by Max Nutrition Inc. Analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule), with the product marketed without an approved NDA or ANDA. The recall affects all lots with expiration date 12/31/2027, totaling 125 boxes distributed nationwide.

Class I Recall: MR. 7 Super Capsules Contain Undeclared Sildenafil and Tadalafil

FDA classified a Class I recall of MR. 7 SUPER 700000 capsules distributed by mR. 7. FDA analysis found undeclared sildenafil and tadalafil. All lot codes with expiration date 12/31/2029 are affected. The recall was initiated by the firm on December 15, 2025 and classified by FDA on March 18, 2026.