January 15, 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 15, 2025DrugsFDA
West-Ward Columbus Inc recalls Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA I
Hazard: Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
January 15, 2025DrugsFDA
FDC Limited recalls Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading
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
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containin
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containi
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
January 15, 2025DrugsFDA
Buy-Herbal recalls Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang,
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
January 8, 2025DrugsFDA
AvKARE recalls Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by
Hazard: LABELING: LABEL MIX-UP
January 8, 2025DrugsFDA
AvKARE recalls Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Dist
Hazard: LABELING: LABEL MIX-UP
January 8, 2025DrugsFDA
Hikma Injectables USA Inc recalls phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Ro
Hazard: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
January 8, 2025DrugsFDA
Hikma Injectables USA Inc recalls ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc
Hazard: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
January 8, 2025DrugsFDA
VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharm
Hazard: Crystallization
January 8, 2025DrugsFDA
VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Phar
Hazard: Crystallization
January 8, 2025DrugsFDA
GNMart LLC recalls FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
Hazard: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
January 8, 2025DrugsFDA
SOMERSET THERAPEUTICS LLC recalls Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somer
Hazard: Failed Impurities/Degradation Specifications
January 8, 2025DrugsFDA
AvKARE recalls Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc.
Hazard: Failed Dissolution Specifications
January 8, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, I
Hazard: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
January 1, 2025DrugsFDA
MXBBB recalls UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Hazard: cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
January 1, 2025DrugsFDA
RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 7051
Hazard: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
January 1, 2025DrugsFDA
Curium US, LLC recalls Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reacti
Hazard: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
January 1, 2025DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC
Hazard: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
January 1, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutic
Hazard: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
January 1, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutica
Hazard: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
January 1, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals
Hazard: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
January 1, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals I
Hazard: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
January 1, 2025DrugsFDA
Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
January 1, 2025DrugsFDA
Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hy
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
January 1, 2025DrugsFDA
Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, H
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
January 1, 2025DrugsFDA
Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hy
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.