February 12, 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: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
February 5, 2025DrugsFDA
McKesson recalls Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRI
Hazard: cGMP Deviations: Product intended for quarantine was inadvertently distributed.
February 5, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b
Hazard: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
February 5, 2025DrugsFDA
Astellas Pharma US Inc. recalls Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma
Hazard: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
February 5, 2025DrugsFDA
Astellas Pharma US Inc. recalls Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:
Hazard: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
February 5, 2025DrugsFDA
The W.S. Badger Company, Inc. recalls BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Compa
Hazard: Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
January 29, 2025DrugsFDA
Appco Pharma LLC recalls Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Hazard: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
January 29, 2025DrugsFDA
SHOPPERS- PLAZA recalls FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA
Hazard: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
January 29, 2025DrugsFDA
First Aid Beauty Ltd recalls First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First
Hazard: CGMP Deviations; product intended for quarantine was inadvertently distributed
January 29, 2025DrugsFDA
Brands International Corporation recalls Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON,
Hazard: CGMP Deviations: lack of adequate release testing.
January 22, 2025DrugsFDA
Viatris Inc recalls Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, M
Hazard: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
January 22, 2025DrugsFDA
Viatris Inc recalls Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Mo
Hazard: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
January 22, 2025DrugsFDA
Amerisource Health Services LLC recalls glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Hea
Hazard: Failed Dissolution Specifications:
January 22, 2025DrugsFDA
Amerisource Health Services LLC recalls Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LL
Hazard: Presence of Foreign Tablets/Capsules
January 22, 2025DrugsFDA
Alcon Research LLC recalls Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth
Hazard: Non-Sterility
January 22, 2025DrugsFDA
Akron Pharma, Inc. recalls Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46,
Hazard: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
January 22, 2025DrugsFDA
Akron Pharma, Inc. recalls Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W
Hazard: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
January 22, 2025DrugsFDA
Akron Pharma, Inc. recalls Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W B
Hazard: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
January 22, 2025DrugsFDA
Akron Pharma, Inc. recalls Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US
Hazard: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
January 22, 2025DrugsFDA
Akron Pharma, Inc. recalls Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ
Hazard: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
January 22, 2025DrugsFDA
Akron Pharma, Inc. recalls Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117
Hazard: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
January 22, 2025DrugsFDA
Akron Pharma, Inc. recalls Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, F
Hazard: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
January 15, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules In
Hazard: Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
January 15, 2025DrugsFDA
Jubilant Draximage Inc., dba Jubilant Radiopharma recalls Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx On
Hazard: Failed Stability Specifications
January 15, 2025DrugsFDA
Rising Pharma Holding, Inc. recalls Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distribu
Hazard: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
January 15, 2025DrugsFDA
Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., E
Hazard: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
January 15, 2025DrugsFDA
Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottl
Hazard: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
January 15, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 2015
Hazard: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
January 15, 2025DrugsFDA
Eugia US LLC recalls Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LL
Hazard: Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
January 15, 2025DrugsFDA
Eugia US LLC recalls medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for:
Hazard: CGMP Deviations