Class I · High risk
PIYANPING Anti-Itch
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
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
Pravastatin Sodium Tablets
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Class I · High risk
Lorazepam Oral Concentrate
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Class I · High risk
Natural Herbal Coffee Ampt
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Class I · High risk
LaBri's Body Health XPLODE 30 capsules Exclusively distribute…
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk
LaBri's Body Health Atomic 60 Capsules Exclusively distributed…
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk
Super Panther 7K Capsules 1250 mg blend
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Class I · High risk
New Kopi Jantan Tradisional Natural Herbs Coffee
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Class I · High risk
D-ZINE Rapid Size and Strength capsules
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Class I · High risk
ULTRA-STEN Rapid Size and Strength capsules
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Class I · High risk
MAN OF STEEL capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
Andropharm M1 Alpha
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk
Andropharm Sten Z
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk
EliquisTablets 5mg
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Class I · High risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Class I · High risk
CaverFlo Natural Herbal Coffee
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Class I · High risk
BRILINTA (ticagrelor)
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class I · High risk
Biotech Underground Tri-Ton Hardcore Formula capsules
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Class I · High risk
Mibelas 24 Fe
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Class I · High risk
GEC LX Laxoplex 60 capsules Dietary Supplement
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class I · High risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled