Civic Data
FDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

Browse

  • All recalls

About

  • About us
  • Guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API

© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 81–100 of 1,000 recalls

Class IITerminated

HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6

Unexo Life Sciences Private Limited

cGMP Deviations

October 24, 2024 · DrugView details →
Class IITerminated

Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc.

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

October 23, 2024 · DrugView details →
Class IITerminated

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc.

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

October 23, 2024 · DrugView details →
Class IITerminated

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc.

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

October 23, 2024 · DrugView details →
Class IITerminated

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

BLI International, Inc.

Superpotent Drug: Stability failure for assay at 6 months test time-point.

October 21, 2024 · DrugView details →
Class IIITerminated

Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

Padagis US LLC

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

October 11, 2024 · DrugView details →
Class IITerminated

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38

ACCORD HEALTHCARE, INC.

Failed Impurities/Degradation Specifications.

October 1, 2024 · DrugView details →
Class ITerminated

Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317

Staska Pharmaceuticals, Inc.

Presence of Particulate Matter: Presence of glass particulates.

September 30, 2024 · DrugView details →
Class IITerminated

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

Fresenius Kabi Compounding, LLC

CGMP violations

September 25, 2024 · DrugView details →
Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →
Class ITerminated

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

Gilead Sciences, Inc.

Presence of Particulate Matter: Presence of glass particle.

September 19, 2024 · DrugView details →
Class ITerminated

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Bionpharma Inc.

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

September 17, 2024 · DrugView details →
← PreviousPage 5 of 50Next →