Class I · High risk
African Black Ant
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
Mojo Risen
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Class I · High risk
Black Ant
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Class II · Moderate risk
Hemo-Stat Solution
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk
Calcitriol Oral Solution 1 mcg/mL
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Class II · Moderate risk
Dextroamphetamine Sulfate Tablets
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Class I · High risk
Lite Fit USA
Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.
Class II · Moderate risk
Red Yeast Rice High Potency Dietary Supplement
Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.
Class II · Moderate risk
Tev-Tropin
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Class III · Low risk
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Class II · Moderate risk
Famotidine Injection 20 mg
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Class II · Moderate risk
QVAR¿ (beclomethasone dipropionate HFA)
Defective Delivery System; defective valve
Class II · Moderate risk
Liothyronine Sodium Tablets
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Class I · High risk
Atropine Sulfate 0.4 mg/ml Injection
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/ml
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Class III · Low risk
Olanzapine Orally Disintegrating Tablets 5 mg
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.