Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
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
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Lamotrigine Orally Disintegrating Tablets
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Class I · High risk
Honeywell eyesaline Eyewash Sterile Isotonic Solution
Non Sterility; contaminated with Klebsiella pneumoniae
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Class I · High risk
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I
Non-Sterility; microbial contamination identified as Bacillus circulans
Class I · High risk
Comfort Shield
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class I · High risk
Docusate Oral 10 mg/mL Oral Syringe
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Class I · High risk
Cetylev (acetylcysteine)
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Class I · High risk
Diocto Liquid
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Class I · High risk
Super Samurai-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ginseng Power-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ninja-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Tiger-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
BLACK GOLD X ADVANCED capsules
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk
BLACK LABEL X capsules
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Class I · High risk
PHENYLephrine 1 mg/10 mL
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Class I · High risk
Cap-Biotin 100 Mg
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class I · High risk
5% Dextrose Injection USP
Non-Sterility: fungal contamination due to leaking containers.
Class I · High risk
Magnesium Sulfate Inj.
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I · High risk
Amikacin Sulfate injection USP
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Class I · High risk
Morphine Sulfate 0.5 mg/mL
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.