Class II · Moderate risk
Buffered Lidocaine
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Stability & shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency.
560 FDA drug recalls with this cause, newest first.
These recalls involve products whose stability data no longer supports the expiry date on the label, or that failed a stability test before that date. A medicine that loses potency early does not just stop working as well; it can also change chemically into something FDA never approved. The fix is usually a shorter shelf life for future lots.
Class II · Moderate risk
Buffered Lidocaine
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class III · Low risk
E-Z-CAT Dry Barium Sulfate for Suspension
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class II · Moderate risk
Alinia (nitazoxanide)
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Class I · High risk
MitoXANTRONE Injection
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Class II · Moderate risk
Ticarcillin Sodium/Potassium Clavulanate
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Class II · Moderate risk
Procaine Penicillin G active pharmaceutical ingredient packaged…
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Class II · Moderate risk
Piperacillin Sodium active pharmaceutical ingredient packaged in…
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Class II · Moderate risk
Amoxicillin Trihydrate active pharmaceutical ingredient packaged…
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 through 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Class II · Moderate risk
Glimepiride Tablets
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Class II · Moderate risk
Ketorolac Tromethamine INJECTION
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Class II · Moderate risk
Fluocinonide Gel USP
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Class III · Low risk
OXYCODONE HYDROCHLORIDE C II Oral Solution USP
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Class III · Low risk
DENBLAN Anticavity Fluoride Toothpaste
Stability Data Does Not Support Expiry
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Class III · Low risk
Glytone Acne
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Class III · Low risk
Photofrin (porfimer sodium)
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Class III · Low risk
VoLumen Barium Sulfate Suspension
Failed Stability Testing: This product is below specification for preservative content.
Class III · Low risk
Fluconazole Oral Suspension
Failed Stability Specifications: this product is below specification for preservative content.
Class III · Low risk
Acyclovir Oral Suspension
Failed Stability Specification; product viscosity and or pH are below 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.