Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box
April 17, 2024
ARG Laboratories, Inc.
3,504 units
FDA Drug
Class II
Ongoing
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Bo
April 17, 2024
ARG Laboratories, Inc.
2,864 units
FDA Drug
Class II
Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Ti
April 17, 2024
ARG Laboratories, Inc.
500 units
FDA Drug
Class II
Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in
April 17, 2024
ARG Laboratories, Inc.
192 units
FDA Drug
Class II
Completed
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
April 12, 2024
Dercher Enterprises, Inc., DBA Gordon Laboratories
5,247 glass jars units
FDA Drug
Class II
Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-34
April 10, 2024
Imprimis NJOF, LLC
3320 bottles units
FDA Drug
Class III
Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
April 10, 2024
Imprimis NJOF, LLC
15,414 units units
FDA Drug
Class III
Ongoing
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
N/A units
FDA Drug
Class III
Ongoing
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
N/A units
FDA Drug
Class III
Ongoing
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
108,192/30 count bottles or 7 count blister packs units
FDA Drug
Class III
Ongoing
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
N/A units
FDA Drug
Class I
Ongoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
April 8, 2024
Dr. Reddy's Laboratories, Inc.
2402 cartons units
FDA Drug
Class I
Ongoing
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 435
April 8, 2024
Dr. Reddy's Laboratories, Inc.
17,332 cartons units
FDA Drug
Class III
Terminated
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC
April 2, 2024
X-Gen Pharmaceuticals Inc.
1283 vials units
FDA Drug
Class III
Terminated
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted
April 2, 2024
X-Gen Pharmaceuticals Inc.
1332 vials units
FDA Drug
Class II
Terminated
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-
March 29, 2024
HONEYWELL INC
10, 605 cartridges units
FDA Drug
Class I
Terminated
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
March 28, 2024
AvKARE
153 cartons units
FDA Drug
Class II
Ongoing
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 05
March 28, 2024
Teva Pharmaceuticals USA, Inc.
5,304 3x10-cartons units
FDA Drug
Class III
Completed
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
March 27, 2024
Esperion
3,480 30-count bottles units
FDA Drug
Class II
Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by:
March 27, 2024
NATCO Pharma Limited
30 bottles units
FDA Drug
Class II
Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Ci
March 26, 2024
Cipla USA, Inc.
59244/3ml FFS packs units
FDA Drug
Class II
Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of
March 26, 2024
Glenmark Pharmaceuticals Inc., USA
6,528 bottles units
FDA Drug
Class III
Terminated
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
March 25, 2024
Novitium Pharma LLC
1,003 bottles units
FDA Drug
Class II
Completed
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
March 25, 2024
Amneal Pharmaceuticals of New York, LLC.
2784 bottles units
FDA Drug
Class I
Ongoing
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Man
March 23, 2024
Aruba Aloe Balm N.V.
9,625 bottles units
FDA Drug
Class I
Ongoing
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
March 23, 2024
Aruba Aloe Balm N.V.
5299 bottles units
FDA Drug
Class II
Ongoing
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
March 22, 2024
IntegraDose Compounding Services LLC
187 cassettes units
FDA Drug
Class II
Terminated
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
March 22, 2024
B. Braun Medical Inc
7,800 bags units
FDA Drug
Class I
Terminated
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Dis
March 21, 2024
Amneal Pharmaceuticals of New York, LLC.
821 bottles units
FDA Drug
Class II
Terminated
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659
March 21, 2024
Lupin Pharmaceuticals Inc.
26,352 bottles units
FDA Drug
Class II
Terminated
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
March 21, 2024
Apothecus Pharmaceutical Corp.
17,280 paper cartons units
FDA Drug
Class I
Ongoing
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
March 19, 2024
Pyramids Wholesale Inc.
12 boxes units
FDA Drug
Class I
Ongoing
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
March 19, 2024
Pyramids Wholesale Inc.
7 boxes units
FDA Drug
Class I
Ongoing
The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
March 19, 2024
Pyramids Wholesale Inc.
10 boxes units
FDA Drug
Class I
Ongoing
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
March 19, 2024
Pyramids Wholesale Inc.
7 pieces units
FDA Drug
Class I
Ongoing
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
March 19, 2024
Pyramids Wholesale Inc.
19 boxes units
FDA Drug
Class I
Ongoing
Weiner Boner Honey, 12g packet, 100% Organic Formula.
March 19, 2024
Pyramids Wholesale Inc.
19 boxes units
FDA Drug
Class I
Ongoing
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
March 19, 2024
Pyramids Wholesale Inc.
N/A units
FDA Drug
Class I
Ongoing
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
March 19, 2024
Pyramids Wholesale Inc.
149 boxes units
FDA Drug
Class I
Ongoing
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
March 19, 2024
Pyramids Wholesale Inc.
45 boxes units
FDA Drug
Class I
Ongoing
Samurai-X Honey 6800, UPC 2 56891 27553 3.
March 19, 2024
Pyramids Wholesale Inc.
N/A units
FDA Drug
Class I
Ongoing
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
March 19, 2024
Pyramids Wholesale Inc.
4,351 pieces units
FDA Drug
Class II
Ongoing
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
March 12, 2024
Hikma Pharmaceuticals USA Inc.
22,644 ampuls units
FDA Drug
Class II
Completed
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed b
March 12, 2024
Eli Lilly & Company
700 vials units
FDA Drug
Class II
Terminated
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wale
March 7, 2024
Teva Pharmaceuticals USA, Inc.
92,676 cartons units
FDA Drug
Class II
Terminated
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
March 6, 2024
B. Braun Medical Inc
22,752 bags units
FDA Drug
Class II
Terminated
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
March 5, 2024
Thea Pharma, Inc.
5,476 bottles units
FDA Drug
Class III
Terminated
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
March 4, 2024
Novitium Pharma LLC
3,940 1000-count bottles units
FDA Drug
Class II
Ongoing
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15,
March 4, 2024
Sun Pharmaceutical Industries Inc.
47,520 bottles units
FDA Drug
Class I
Ongoing
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 420
March 4, 2024
PAR Sterile Products LLC
466 vials units