Class III · Low risk
Cetirizine Hydrochloride Syrup
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
FDA Drug Recalls
170 recalls · Class III, newest first
Class III · Low risk
VoLumen Barium Sulfate Suspension
Failed Stability Testing: This product is below specification for preservative content.
Class III · Low risk
Folic Acid Injection
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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 III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Paclitaxel Injection
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Class III · Low risk
Bumetanide Tablets USP 0.5 mg. Rx Only
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Class III · Low risk
Glipizide XL
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Class III · Low risk
Glucotrol XL
Failed Dissolution Specification; 8 hr stability timepoint
Class III · Low risk
Acyclovir Oral Suspension
Failed Stability Specification; product viscosity and or pH are below specification.
Class III · Low risk
Ciclopirox Shampoo 1%
Subpotent. drug
Class III · Low risk
Potassium Chloride
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Class III · Low risk
G & W Fluocinolone Acetonide Cream USP 0.025%
Failed Content Uniformity Specifications; at the 18 month time point.
Class III · Low risk
Hydroxychloroquine Sulfate Tablets
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Class III · Low risk
Ketoconazole Shampoo
Subpotent
Class III · Low risk
Acanya (Clindamycin Phosphate and Benzoyl Peroxide)
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Class III · Low risk
Endometrin
Discoloration; due to prolonged heat exposure.
Class III · Low risk
Venlafaxine
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Class III · Low risk
Loratadine 24 HR-OTC
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.