FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1481–1500 of 17,711 recalls

Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

Samurai-X Honey 6800, UPC 2 56891 27553 3.

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

Class I

Ongoing

ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

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.

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.

Pyramids Wholesale Inc.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

March 19, 2024 · DrugView details →

Class IICompleted

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 by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01

Eli Lilly & Company

CGMP Deviations

March 12, 2024 · DrugView details →

Class IIOngoing

Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01

Hikma Pharmaceuticals USA Inc.

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

March 12, 2024 · DrugView details →

Class IITerminated

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 Wales, PA 19454, NDC 0093-2140-62

Teva Pharmaceuticals USA, Inc

Failed Dissolution Specifications

March 7, 2024 · DrugView details →

Class IITerminated

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

B. Braun Medical Inc

Lack 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.

March 6, 2024 · DrugView details →

Class IITerminated

Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

Thea Pharma, Inc.

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

March 5, 2024 · DrugView details →

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: 42023-206-01

Par Sterile Products LLC

Presence of Particulate Matter.

March 4, 2024 · DrugView details →

Class IIOngoing

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, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

March 4, 2024 · DrugView details →

Class IIOngoing

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, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

March 4, 2024 · DrugView details →

Class IIITerminated

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

Novitium Pharma LLC

Cross Contamination with Other Products:(mycophenolate mofetil).

March 4, 2024 · DrugView details →

Class IICompleted

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)81305-100-03

Specialty Process Labs LLC

Failed Stability Specifications

March 1, 2024 · DrugView details →

Class IICompleted

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.

Specialty Process Labs LLC

Failed Stability Specifications

March 1, 2024 · DrugView details →

Class IIOngoing

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 Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1

SSM Health Care St. Louis DBA SSM St. Clare Health Center

Lack of Assurance of Sterility: Firm did not perform process validation.

February 29, 2024 · DrugView details →

← PreviousPage 75 of 886Next →