Class I · High risk Ongoing
Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC…
Reason Chemical contamination: Presence of benzene
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By…
Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Class I · High risk Terminated
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the…
Class I · High risk Terminated
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the…
Class I · High risk Terminated
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products…
Class I · High risk Terminated
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode…
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the…
Class I · High risk Terminated
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved…
Class I · High risk Terminated
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved…
Class I · High risk Terminated
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a…
Reason Non-sterility
Class I · High risk Terminated
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN…
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the…
Class I · High risk Terminated
Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO…
Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number…
Class I · High risk Terminated
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO…
Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number…
Class I · High risk Terminated
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN…
Reason Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA…
Class I · High risk Terminated
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only…
Reason Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class I · High risk Terminated
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL…
Reason Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Class I · High risk Terminated
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL…
Reason Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class I · High risk Terminated
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC…
Reason Microbial Contamination of Non-Sterile Product
Class I · High risk Terminated
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel…
Reason Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class I · High risk Terminated
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale…
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I · High risk Terminated
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City…
Reason Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class I · High risk Terminated
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology…
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I · High risk Ongoing
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by…
Reason Superpotent Drug
Class I · High risk Terminated
Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter…
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by…
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dist. by…
Reason Chemical contamination: presence of benzene