December 17, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,
Hazard: Defective container - seal not adhering to bottles
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
December 17, 2025DrugsFDA
Winder Laboratories, LLC recalls Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder
Hazard: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
December 17, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prad
Hazard: Cross Contamination with Other Products
December 17, 2025DrugsFDA
Fagron Compounding Services recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe
Hazard: Incorrect Product Formulation
December 17, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Man
Hazard: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
December 17, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in
Hazard: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P
Hazard: Failed stability specifications: Out of specification for hardness test
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P
Hazard: Failed stability specifications: Out of specification for hardness test
December 10, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Eu
Hazard: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
December 10, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Eu
Hazard: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
December 10, 2025DrugsFDA
Safecor Health, LLC recalls Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manu
Hazard: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceut
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA,
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Ave
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in In
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Ma
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, M
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, O
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA,
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeb
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Blossom Pharmaceuticals recalls Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 U
Hazard: cGMP deviations
December 10, 2025DrugsFDA
Park Avenue Compounding recalls Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, M
Hazard: CGMP Deviations
December 10, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-87
Hazard: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
December 10, 2025DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavi
Hazard: Defective Container - A defect in the side-seal which allows leakage of product.