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

Related Categories