Class III · Low risk
Quelicin (Succinylcholine Chloride)
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class III · Low risk
Normosol-M and 5% Dextrose
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Class I · High risk
APEXXX tablets
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Class II · Moderate risk
Screenses Color Sunscreen
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Screenses Color Sunscreen Tinted facial make-up compact
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Women
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Salises Facial Moisturizing Acne Treatment Gel
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Antiperspirant Solution
cGMP Deviations; product does not comply with cGMP requirements
Class III · Low risk
Amidate (Etomidate Injection, USP)
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Class I · High risk
MIRACLE DIET 30 capsules
Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
Class I · High risk
MIRACLE ROCK 48 capsules
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Class II · Moderate risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Class I · High risk
Akttive High Performance Fat Burner Gold dietary supplement capsules
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Class I · High risk
Zero Xtreme High Performance Fat Burner capsules
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk
Ceftriaxone 1 gm/50 mL D5W
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Class II · Moderate risk
Cefepime 2 gm/100 mL 0.9%NS
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.