Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Impurities & degradation products
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present.
704 FDA drug recalls with this cause, newest first.
Every drug has a specification for how much of each impurity or breakdown product it may contain. These recalls are lots that exceeded one of those limits - often a related compound formed during manufacturing or storage, or an out-of-specification result found during routine stability testing. Nitrosamine impurities are common enough to get their own category; everything else lands here.
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class III · Low risk
Tolterodine Tartrate Tablets
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Class III · Low risk
Famotidine for Oral Suspension
Failed Impurity/Degradation Specification; 12-month stability time point
Class III · Low risk
Diltiazem HCl Extended Release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class III · Low risk
Cardura XL
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Class III · Low risk
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Apri (desogestrel and ethinyl estradiol tablets USP)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
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 III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Class III · Low risk
Children's Cetirizine Hydrochloride Chewable Tablets
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Class III · Low risk
Cetirizine Hydrochloride Chewable Tablets
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Class II · Moderate risk
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Class II · Moderate risk
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Class II · Moderate risk
triple therapy
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Class III · Low risk
Risperidone Oral Solution
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Class III · Low risk
QVAR¿ (beclomethasone dipropionate HFA)
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Class III · Low risk
Carisoprodol Tablets
Failed Impurity/degradation Specification
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.