Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd,
February 13, 2025
Zydus Pharmaceuticals USA Inc
36,978 vials units
FDA Drug
Class II
Ongoing
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in C
February 12, 2025
Wuxi Medical lnstrument Factory Co., Ltd.
37,500 Boxes units
FDA Drug
Class II
Terminated
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
February 10, 2025
Nephron Sterile Compounding Center LLC
4,190 bottles units
FDA Drug
Class II
Ongoing
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
5.1 kg units
FDA Drug
Class II
Ongoing
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
120.0 kg units
FDA Drug
Class II
Ongoing
Alprostadil Container Description: Amber color bottle
February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
3.0 gm units
FDA Drug
Class II
Ongoing
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
400.0 gm units
FDA Drug
Class II
Ongoing
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
150.0 gm units
FDA Drug
Class II
Ongoing
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
February 7, 2025
Aspen Biopharma Labs Pvt., Ltd.
4.0 kg units
FDA Drug
Class II
Completed
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
February 6, 2025
Padagis US LLC
4944 cartons units
FDA Drug
Class II
Ongoing
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cr
February 6, 2025
Sun Pharmaceutical Industries Inc.
9840 bottles units
FDA Drug
Class II
Ongoing
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
February 4, 2025
AvKARE
1266 bottles units
FDA Drug
Class II
Ongoing
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
January 31, 2025
Direct Rx
477 bottles. units
FDA Drug
Class II
Completed
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
January 31, 2025
Fagron Compounding Services
1330 bags units
FDA Drug
Class I
Ongoing
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery
January 31, 2025
Alvogen, Inc
112,128 cartons (5 pouches/carton) units
FDA Drug
Class II
Ongoing
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Ro
January 30, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
6997 cartons units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
87,600 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
80,160 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
119,040 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
58,368 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
70,032 bottles units
FDA Drug
Class II
Ongoing
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.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
133,824 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
56,208 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
58,416 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
175,920 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
39,168 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
53,952 bottles units
FDA Drug
Class II
Ongoing
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
190,320 bottles units
FDA Drug
Class II
Ongoing
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.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
120,000 bottles units
FDA Drug
Class II
Ongoing
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.
January 29, 2025
Glenmark Pharmaceuticals Inc., USA
233,040 bottles units
FDA Drug
Class I
Ongoing
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
January 28, 2025
Ascent Consumer Products Inc.
4,176 cartons units
FDA Drug
Class I
Ongoing
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
January 28, 2025
Ascent Consumer Products Inc.
unknown units
FDA Drug
Class I
Ongoing
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
January 28, 2025
Ascent Consumer Products Inc.
unknown units
FDA Drug
Class II
Terminated
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.
January 24, 2025
RemedyRepack Inc.
247 blister packs units
FDA Drug
Class II
Ongoing
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
January 24, 2025
SKY PACKAGING
FDA Drug
Class II
Ongoing
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
January 24, 2025
SKY PACKAGING
FDA Drug
Class II
Ongoing
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
January 23, 2025
FDC Limited
118104 bottles units
FDA Drug
Class II
Ongoing
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.
January 22, 2025
Glenmark Pharmaceuticals Inc., USA
FDA Drug
Class II
Ongoing
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.
January 22, 2025
Glenmark Pharmaceuticals Inc., USA
FDA Drug
Class II
Ongoing
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
January 21, 2025
AvKARE
341 cartons units
FDA Drug
Class II
Ongoing
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
January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
82,281 cartons units
FDA Drug
Class I
Ongoing
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
January 21, 2025
Provepharm Inc.
24640 vials units
FDA Drug
Class II
Ongoing
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
January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
94,349 cartons units
FDA Drug
Class II
Ongoing
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
January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
27,525 cartons units
FDA Drug
Class III
Terminated
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
January 17, 2025
The W.S. Badger Company, Inc.
4,834 tins units
FDA Drug
Class II
Ongoing
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
January 17, 2025
Mckesson
192 vials units
FDA Drug
Class III
Completed
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
January 16, 2025
Appco Pharma LLC
1380 bottles units
FDA Drug
Class II
Completed
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
January 13, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
a) 6408 boxes and b)1488 boxes units
FDA Drug
Class II
Ongoing
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
January 10, 2025
Teva Pharmaceuticals USA, Inc.
34,636 cartons units
FDA Drug
Class II
Ongoing
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
January 8, 2025
Johnson, S C and Son, Inc
57,184 bottles units