Drug Recalls
Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.
USV Private Limited
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
ASTRAZENECA PHARMACEUTICALS
Lack of Assurance of Sterility:
Mohamed Hagar
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Sandoz Lisinopril HCT 20/25mg
Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…
Rising Pharma Holding, Inc.
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) inst…
Teva Pharmaceuticals USA, Inc
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit fo…
Teva Pharmaceuticals USA, Inc
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit fo…
Teva Pharmaceuticals USA, Inc
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit fo…
VIONA PHARMACEUTICALS INC
Discoloration
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Advanced Pharmaceutical Technology, Inc.
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Church & Dwight Co., Inc.
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Aspiro Pharma Limited
Presence of Particulate Matter: Particulate matter identified as glass
AHCC
Product safety. Verify if your product is affected.Stop taking the product if you have milk allergy .Consult your healthcare provider for any health concerns.Co…
Acella Pharmaceuticals, LLC
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Acuity Specialty Products, Inc.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not…
Acuity Specialty Products, Inc.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not…
Medline Industries, LP
Subpotent Drug
Dr. Reddy's Laboratories, Inc.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.