Class I · High risk
Nifedipine WSP 0.2% Ointment
Subpotent and Superpotent 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
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
CVS Health Magnesium Citrate SALINE LAXATIVE
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Class I · High risk
Arti King Refozado con Ortiga y Omega 3 Tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Class I · High risk
SnoreStop NasoSpray
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Class I · High risk
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
Class I · High risk
Magnesium Hydroxide 2400 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Magnesium Hydroxide 1200 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
Class I · High risk
Artri King Reforzado con Ortiga y Omega 3 tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk
Ortiga mas Ajo Rey Reforzado con Omega 3
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk
Artri Ajo King Reforzado con Ortiga y Omega 3 tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk
Artri King Reforzado con Ortiga Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Class I · High risk
Tegsedi (inotersen)
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class I · High risk
Anagrelide Capsules USP
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Class I · High risk
Tacrolimus
Subpotent drug
Class I · High risk
Tacrolimus
Subpotent drug
Class I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Class I · High risk
Humalog KwikPen
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent
Chemical contamination: presence of benzene
Class I · High risk
The Mandalorian Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain benzene
Class I · High risk
Mickey Mouse Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain methanol
Class I · High risk
Pink Pussycat SENSUAL ENHANCEMENT capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.