Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,101–1,150 of 1,842

Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 29, 2025
Glenmark Pharmaceuticals Inc., USA
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II
Drug Recall · January 28, 2025
Ascent Consumer Products Inc.
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I
Drug Recall · January 28, 2025
Ascent Consumer Products Inc.
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I
Drug Recall · January 28, 2025
Ascent Consumer Products Inc.
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distri
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I
Drug Recall · January 24, 2025
RemedyRepack Inc.
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II
Drug Recall · January 24, 2025
SKY PACKAGING
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN
Failed Impurities/Degradation Specifications
Class II
Drug Recall · January 24, 2025
SKY PACKAGING
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Pa
Failed Impurities/Degradation Specifications
Class II
Drug Recall · January 23, 2025
FDC Limited
Timolol 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 Jerse
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.
Class II
Drug Recall · January 22, 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol 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.
Class II
Drug Recall · January 22, 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II
Drug Recall · January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Drug Recall · January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and D
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Drug Recall · January 21, 2025
Provepharm Inc.
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
Presence of Particulate Matter.
Class I
Drug Recall · January 21, 2025
AvKARE
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Out of Specification for Dissolution
Class II
Drug Recall · January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and D
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Drug Recall · January 17, 2025
McKesson
Inflectra (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
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class II
Drug Recall · January 17, 2025
The W.S. Badger Company, Inc.
BADGER 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.
Class III
Drug Recall · January 16, 2025
Appco Pharma LLC
Venlafaxine 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
Class III
Drug Recall · January 13, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Duloxetine 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 D
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Class II
Drug Recall · January 10, 2025
Teva Pharmaceuticals USA, Inc
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Class II
Drug Recall · January 8, 2025
Johnson, S C and Son, Inc
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Class II
Drug Recall · January 7, 2025
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
Superpotent; sodium benzoate preservative
Class III
Drug Recall · January 7, 2025
Amerisource Health Services LLC
Clobazam 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 60687-42
Presence of Foreign Tablets/Capsules
Class II
Drug Recall · December 30, 2024
Granules Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceutica
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.
Class II
Drug Recall · December 30, 2024
Rising Pharma Holding, Inc.
Duloxetine 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.
Class II
Drug Recall · December 30, 2024
Rising Pharma Holding, Inc.
Duloxetine 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.
Class II
Drug Recall · December 30, 2024
Rising Pharma Holding, Inc.
Duloxetine 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.
Class II
Drug Recall · December 27, 2024
Eugia US LLC
Progesterone 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.
Class II
Drug Recall · December 23, 2024
First Aid Beauty Ltd
First 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
Class II
Drug Recall · December 23, 2024
Astellas Pharma US Inc.
Astagraf 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
Class I
Drug Recall · December 23, 2024
Viatris Inc
Cardura 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.
Class II
Drug Recall · December 23, 2024
Astellas Pharma US Inc.
Prograf (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
Class I
Drug Recall · December 23, 2024
Viatris Inc
Cardura 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.
Class II
Drug Recall · December 20, 2024
Lupin Pharmaceuticals Inc.
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pit
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Class II
Drug Recall · December 20, 2024
ENDO USA, Inc.
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class I
Drug Recall · December 19, 2024
Hikma Injectables USA Inc
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., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II
Drug Recall · December 19, 2024
Hikma Injectables USA Inc
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II
Drug Recall · December 19, 2024
West-Ward Columbus Inc
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class III
Drug Recall · December 18, 2024
Granules Pharmaceuticals Inc.
Colchicine 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.
Class II
Drug Recall · December 18, 2024
Alcon Research LLC
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Non-Sterility
Class I
Drug Recall · December 18, 2024
AvKARE
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
LABELING: LABEL MIX-UP
Class III
Drug Recall · December 18, 2024
AvKARE
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
LABELING: LABEL MIX-UP
Class III
Drug Recall · December 18, 2024
Eugia US LLC
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acet
CGMP Deviations
Class II