Class I · High risk
Regenecare Ha
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
Chlorhexidine Gluconate Oral Rinse USP
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Class I · High risk
Class I · High risk
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Fentanyl-Bupivacaine HCL Pf Injectable 3000mcg-12mg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Lioresal Pf Injectable 7.5mg-1625mcg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Non-Sterility
Class I · High risk
Smart Care HAND SANITIZER
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Class I · High risk
Goldenseal POWDER
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk
Cord Care POWDER
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk
Happy Ducts Compress
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk
NP Thyroid 120
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I · High risk
NP Thyroid 15
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I · High risk
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Class I · High risk
Leafree Instant Hand Sanitizer Aloe Vera
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Class I · High risk
Red-E Tablet
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.