Class II · Moderate risk
Testosterone Cypionate for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
FDA Drug Recalls
1,273 recalls, newest first
Class II · Moderate risk
Polidocanol 5% Solution for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Cyanocobalamin for Intramuscular Or Subcutaneous Use Only
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Liver Derivative Complex for injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Polidocanol 0.5% Solution for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
Class II · Moderate risk
PROMETHAZINE HYDROCHLORIDE Tablets
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Class I · High risk
African Black Ant
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
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.