Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL…
Reason Lack of Processing Controls.
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe)…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi…
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class II · Moderate risk Ongoing
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05)…
Reason CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot…
Class II · Moderate risk Ongoing
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer…
Reason CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk Ongoing
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer…
Reason CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk Ongoing
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed…
Reason Failed Dissolution Specifications.
Class II · Moderate risk Completed
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit…
Reason Sub-Potent Drug: Subpotent assay results during stability testing.