Drug Recalls
RSS ↗1,842 drug recalls from federal enforcement feeds.
Showing 1,551–1,600 of 1,842
- Class III
Drug Recall · March 25, 2024
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 70954-200-10Failed Impurities/Degradation Specifications
- Class II
Drug Recall · March 25, 2024
Amneal Pharmaceuticals of New York, LLC
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.Failed Dissolution Specifications
- Class I
Drug Recall · March 23, 2024
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 , ManChemical Contamination: Product manufactured with ethanol API that contains methanol
- Class I
Drug Recall · March 23, 2024
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 5Chemical Contamination: Product manufactured with ethanol API that contains methanol
- Class II
Drug Recall · March 22, 2024
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00Lack of assurance of sterility: bags have the potential to leak..
- Class II
Drug Recall · March 22, 2024
IntegraDose Compounding Services LLC
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 71139-6030-1Lack of Assurance of Sterility: leaking bags
- Class I
Drug Recall · March 21, 2024
Amneal Pharmaceuticals of New York, LLC
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, DisSuperpotent Drug: Due to overfilling of drug powder
- Class I
Drug Recall · March 19, 2024
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Samurai-X Honey 6800, UPC 2 56891 27553 3.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/AMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
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.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'LMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Weiner Boner Honey, 12g packet, 100% Organic Formula.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class II
Drug Recall · March 12, 2024
Hikma Pharmaceuticals USA Inc.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- Class II
Drug Recall · March 7, 2024
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 WaleFailed Dissolution Specifications
- Class II
Drug Recall · March 6, 2024
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 0264-1944-20Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
- Class II
Drug Recall · March 5, 2024
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
- Class II
Drug Recall · March 4, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 80mg, 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, DCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Class I
Drug Recall · March 4, 2024
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: 420Presence of Particulate Matter.
- Class II
Drug Recall · March 4, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
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,CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Class III
Drug Recall · March 4, 2024
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 70954-201-20Cross Contamination with Other Products:(mycophenolate mofetil).
- Class II
Drug Recall · March 1, 2024
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.Failed Stability Specifications
- Class II
Drug Recall · March 1, 2024
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03Failed Stability Specifications
- Class II
Drug Recall · February 29, 2024
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility,Lack of Assurance of Sterility: Firm did not perform process validation.
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing FLack of Assurance of Sterility: Firm did not perform process validation.
- Class II
Drug Recall · February 22, 2024
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520,Failed Stability Specification: Water determination was found not complying with specification.
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class II
Drug Recall · February 20, 2024
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Class III
Drug Recall · February 20, 2024
Contract Pharmaceuticals Limited Canada
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class III
Drug Recall · February 20, 2024
Contract Pharmaceuticals Limited Canada
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.