Class II · Moderate risk
Chlorthalidone Tablets USP 25 mg
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
FDA Drug Recalls
1,018 recalls, newest first
Class I · High risk
Paragard T380a
Non-sterility
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class I · High risk
MegMan Performance Booster
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Morphine Sulfate PF 25 mg/25mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class I · High risk
HYDROmorphone HCl PF 10 mg/50 mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class I · High risk
Hard Dawn
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class II · Moderate risk
Cystex Tablet
CGMP Deviations
Class II · Moderate risk
DBI Magnums Tablet
CGMP Deviations
Class II · Moderate risk
Coated Back Relief Tablet
CGMP Deviations
Class II · Moderate risk
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg)
CGMP Deviations
Class II · Moderate risk
Back Relief II
CGMP Deviations
Class II · Moderate risk
Pain Aid PMF Caplet
CGMP Deviations
Class II · Moderate risk
Normed Fem Tablet
CGMP Deviations
Class II · Moderate risk
APAP 325 mg
CGMP Deviations
Class II · Moderate risk
Migrenol Caplet
CGMP Deviations
Class II · Moderate risk
Coated Phenylephrine HCl 5mg Tablet
CGMP Deviations
Class II · Moderate risk
Phenylephrine HCl 5 mg Tablet
CGMP Deviations
Class II · Moderate risk
Ephedrine 25 Guaifenesin 200 Tablet
CGMP Deviations
Class II · Moderate risk
Nutralox Peppermint Antacid
CGMP Deviations
Class II · Moderate risk
Spearmint Antacid Tablet
CGMP Deviations
Class II · Moderate risk
Trial Antacid Tablet
CGMP Deviations