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 1401–1420 of 17,711 recalls

Class IITerminated

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

Lupin Pharmaceuticals Inc.

Defective container: lack of seal integrity.

May 8, 2024 · DrugView details →

Class IIOngoing

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

MACLEODS PHARMA USA, INC

Presence of foreign substance: plastic-like substance.

May 7, 2024 · DrugView details →

Class IIOngoing

Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01.

PACIRA PHARMACEUTICALS INC

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

May 7, 2024 · DrugView details →

Class IIOngoing

Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00

Rubicon Research Private Limited

Presence of Foreign Substance: metal in tablet

May 6, 2024 · DrugView details →

Class IITerminated

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

RemedyRepack Inc.

Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol

May 2, 2024 · DrugView details →

Class IIIOngoing

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

May 1, 2024 · DrugView details →

Class IIOngoing

Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9

Pharma Nobis LLC

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

May 1, 2024 · DrugView details →

Class IIOngoing

CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.

Pharma Nobis LLC

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

May 1, 2024 · DrugView details →

Class IIICompleted

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

Hikma Injectables USA Inc

Labeling: Wrong Barcode

April 30, 2024 · DrugView details →

Class IICompleted

Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10

Viatris Inc

Failed Impurities/Degradation Specifications

April 30, 2024 · DrugView details →

Class IICompleted

Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

Viatris Inc

Failed Impurities/Degradation Specifications

April 30, 2024 · DrugView details →

Class ICompleted

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Hikma Injectables USA Inc

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

April 29, 2024 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.

Breckenridge Pharmaceutical, Inc

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

April 29, 2024 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Breckenridge Pharmaceutical, Inc

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

April 29, 2024 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.

Breckenridge Pharmaceutical, Inc

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

April 29, 2024 · DrugView details →

Class IIOngoing

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00

Rubicon Research Private Limited

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

April 26, 2024 · DrugView details →

Class IITerminated

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ

FDC Limited

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

April 25, 2024 · DrugView details →

Class IIOngoing

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

Sagent Pharmaceuticals

Presence of Particulate Matter: Potential for black particulates in the drug product.

April 25, 2024 · DrugView details →

Class IIICompleted

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77

Viatris Inc

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

April 25, 2024 · DrugView details →

Class IITerminated

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

Lupin Pharmaceuticals Inc.

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

April 24, 2024 · DrugView details →

← PreviousPage 71 of 886Next →