August 13, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Phila
Hazard: Presence of foreign substance: identified as aluminum.
August 13, 2025DrugsFDA
Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142
Hazard: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
August 13, 2025DrugsFDA
Cardinal Health Inc. recalls Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Hazard: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
August 13, 2025DrugsFDA
Cardinal Health Inc. recalls Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 5
Hazard: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
August 13, 2025DrugsFDA
Direct Rx recalls Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
August 13, 2025DrugsFDA
Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Ph
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
August 13, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Pan
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steril
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) su
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steril
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steri
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2m
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
AEQUITA PHARMACY recalls Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steril
Hazard: Lack of Processing Controls.
August 13, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
August 6, 2025DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, N
Hazard: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
August 6, 2025DrugsFDA
Nostrum Laboratories, Inc. recalls Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-
Hazard: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
August 6, 2025DrugsFDA
Strides Pharma, Inc. recalls Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Dis
Hazard: Failed Dissolution Specifications.
August 6, 2025DrugsFDA
Pfizer Inc. recalls Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed b
Hazard: CGMP Deviations; particulates identified during visual inspection
August 6, 2025DrugsFDA
Pfizer Inc. recalls Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed b
Hazard: CGMP Deviations; particulates identified during visual inspection
August 6, 2025DrugsFDA
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran
Hazard: Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
August 6, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceu
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
July 30, 2025DrugsFDA
Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by
Hazard: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
July 30, 2025DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Hazard: CGMP Deviations; potential temperature excursions due to transit delays