Class I · High risk
0.9 % Sodium Chloride Injection USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class I · High risk
Cefazolin for Injection USP and Dextrose Injection USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Cefazolin for Injection USP and Dextrose Injections USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Cefepime for Injections USP and Dextrose Injection USP
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Ceftriaxone for Injection and Dextrose Injection
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
Cefoxitin for Injection and Dextrose Injection
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Class I · High risk
5% Dextrose Injection
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Class I · High risk
vitaliKOR Ready When You Are
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Class I · High risk
NATURECT Capsules Dietary Supplement 500 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Class I · High risk
P-BOOST Capsules Dietary Supplement 500 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Class I · High risk
RezzRX capsules
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Class I · High risk
Clinimix 5/15 sulfite-free
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class I · High risk
Clinimix E 4.25/10 sulfite-free
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class I · High risk
Clinimix 4.25/25 sulfite-free
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class I · High risk
50 mg Nitroglycerin in 5% Dextrose Injection
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Class I · High risk
eXtenZone capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b
Class I · High risk
MaXtremeZEN capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved
Class I · High risk
Rhino 5 capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class II · Moderate risk
Phenylephrine Nasal 1% Spray
Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablet
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Class III · Low risk
Fluconazole Oral Suspension
Failed Stability Specifications: this product is below specification for preservative content.
Class I · High risk
Glycopyrrolate
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.