Drug and pharmaceutical recalls
17658 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2025-02-12FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IICarvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- 2025-02-12FDA-DrugFDC LimitedClass IITimolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
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.
- 2025-02-05FDA-DrugMcKessonClass IIInflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
- 2025-02-05FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IIDuloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
- 2025-02-05FDA-DrugAstellas Pharma US Inc.Class IPrograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- 2025-02-05FDA-DrugAstellas Pharma US Inc.Class IAstagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- 2025-02-05FDA-DrugThe W.S. Badger Company, Inc.Class IIIBADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
- 2025-01-29FDA-DrugAppco Pharma LLCClass IIIVenlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
- 2025-01-29FDA-DrugSHOPPERS- PLAZAClass IFOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
- 2025-01-29FDA-DrugFirst Aid Beauty LtdClass IIFirst Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
CGMP Deviations; product intended for quarantine was inadvertently distributed
- 2025-01-29FDA-DrugBrands International CorporationClass IIKissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
CGMP Deviations: lack of adequate release testing.
- 2025-01-22FDA-DrugViatris IncClass IICardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- 2025-01-22FDA-DrugViatris IncClass IICardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- 2025-01-22FDA-DrugAmerisource Health Services LLCClass IIglipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
Failed Dissolution Specifications:
- 2025-01-22FDA-DrugAmerisource Health Services LLCClass IIClobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Presence of Foreign Tablets/Capsules
- 2025-01-22FDA-DrugAlcon Research LLCClass ISystane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Non-Sterility
- 2025-01-22FDA-DrugAkron Pharma, Inc.Class IIIDiphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- 2025-01-22FDA-DrugAkron Pharma, Inc.Class IIIDiphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- 2025-01-22FDA-DrugAkron Pharma, Inc.Class IIIDiphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- 2025-01-22FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- 2025-01-22FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- 2025-01-22FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- 2025-01-22FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- 2025-01-15FDA-DrugGranules Pharmaceuticals Inc.Class IIMetformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
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.
- 2025-01-15FDA-DrugJubilant Draximage Inc., dba Jubilant RadiopharmaClass IIKit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
Failed Stability Specifications
- 2025-01-15FDA-DrugRising Pharma Holding, Inc.Class IIDuloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- 2025-01-15FDA-DrugRising Pharma Holding, Inc.Class IIDuloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- 2025-01-15FDA-DrugRising Pharma Holding, Inc.Class IIDuloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- 2025-01-15FDA-DrugGranules Pharmaceuticals Inc.Class IIColchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
- 2025-01-15FDA-DrugEugia US LLCClass IIProgesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
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