Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
FDA Drug Recalls
18,003 recalls, newest first
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
Sterile Water for Injection
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Class II · Moderate risk
Vitamin C (ascorbic acid)
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
Class II · Moderate risk
Relumins Advanced Glutathione
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Class II · Moderate risk
Saluta (reduced glutathione)
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Class II · Moderate risk
Tatiomax (reduced glutathione/hydrolyzed collagen)
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk
Laroscorbine Platinium
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
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.