Class I · High risk
BLUE Diamond PLATINUM Capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
BLUE Diamond Pill
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class I · High risk
libigrow XXXTREME Capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class I · High risk
libigrow capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Class II · Moderate risk
Prednisone tablets
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class III · Low risk
Caziant (desogestrel and ethinyl estradiol)
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Class II · Moderate risk
Temodar (temozolomide)
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Class III · Low risk
Perindopril Erbumine Tablets
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Class I · High risk
WOW, Health Enterprises
Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
Class III · Low risk
Divalproex Sodium Delayed-Release Tablets
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Class III · Low risk
Bronkaid Dual Action Formula
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Class II · Moderate risk
Propylthiouracil Tablets
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Class II · Moderate risk
Lisinopril Tablets
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Class I · High risk
Hydrocodone bitartrate and acetaminophen Tablets
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class II · Moderate risk
Oxygen
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Class II · Moderate risk
PredniSONE Tablets
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Class II · Moderate risk
PredniSONE Tablets
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Class I · High risk
Cyanocobalamin 1000 mcg/ml
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class I · High risk
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class II · Moderate risk
Isoniazid Tablets 300 mg tablets USP
Failed Dissolution Specifications; 36 month stability timepoint
Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.