Class I · High risk
Reumofan Plus Tablets
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Class I drug recalls - the high-risk category
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Class I · High risk
Mojo Nights for Her
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class I · High risk
Mojo Nights
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class I · High risk
HYDROmorphone HCl Injection
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Class I · High risk
Trastuzumab Kit containing 1 vial Trastuzumab
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Class I · High risk
Z-ROCK All Natural Male Supplement. 1 capsule blister pack
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Class I · High risk
X-ROCK 3 Day Pill For Men
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Class I · High risk
Vecuronium Bromide for Injection
Presence of Particulate Matter
Class I · High risk
V Maxx Rx
Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
Class I · High risk
a) Firminite 805 mg is packaged in 2 count
Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.
Class I · High risk
HYDROmorphone HCl Injection
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Class I · High risk
X-ROCK For Men
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Class I · High risk
Morphine Sulfate Injection
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Class I · High risk
Blue Male Enhancement Pill
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Class I · High risk
Japan Weight Loss Blue Capsules
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Class I · High risk
Man King Capsules
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Class I · High risk
Hard Ten Days Capsule
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Class I · High risk
Actra-SX 500 Capsules
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Class I · High risk
Argatroban Injection 50 mg per 50ml
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Class I · High risk
metFORMIN ER Tablets
Labeling: Label Mix up; product labeled did not indicated Extended Release
Class I · High risk
Oxycodone HCl Oral Concentrate
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Class I · High risk
Taztia XT (Diltiazem HCl)
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Class I · High risk
Morphine Sulfate Immediate Release tablet
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Class I · High risk
Morphine Sulfate Extended Release tablet
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Class I · High risk
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.