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  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 661–680 of 17,683 recalls

Class IOngoing

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries, LLC

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

July 17, 2025 · DrugView details →
Class IOngoing

KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

DermaRite Industries, LLC

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

July 17, 2025 · Drug
View details →
Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.

Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

July 15, 2025 · DrugView details →
Class IIOngoing

Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.

Nostrum Laboratories, Inc.

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

July 11, 2025 · DrugView details →
Class IIOngoing

Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313

A.P. Deauville, LLC

CGMP Deviations

July 10, 2025 · DrugView details →
Class IIOngoing

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02

Pfizer Inc.

CGMP Deviations; particulates identified during visual inspection

July 10, 2025 · DrugView details →
Class IIOngoing

Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194

A.P. Deauville, LLC

CGMP Deviations

July 10, 2025 · DrugView details →
Class IIOngoing

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04

Pfizer Inc.

CGMP Deviations; particulates identified during visual inspection

July 10, 2025 · DrugView details →
Class IIOngoing

Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224

A.P. Deauville, LLC

CGMP Deviations

July 10, 2025 · DrugView details →
Class IIICompleted

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

Imprimis NJOF, LLC

Sub-Potent Drug: Subpotent assay results during stability testing.

July 9, 2025 · DrugView details →
Class IIOngoing

Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy

Boothwyn Pharmacy LLC

Subpotent Drug

July 9, 2025 · DrugView details →
Class IIOngoing

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

Ascend Laboratories, LLC

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

July 9, 2025 · DrugView details →
Class IIIOngoing

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

Boothwyn Pharmacy LLC

Subpotent Drug

July 9, 2025 · DrugView details →
Class IICompleted

Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

Imprimis NJOF, LLC

Sub-Potent Drug: Subpotent assay results during stability testing.

July 9, 2025 · DrugView details →
Class IIOngoing

Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy

Boothwyn Pharmacy LLC

Subpotent Drug

July 9, 2025 · DrugView details →
Class IIOngoing

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

Strides Pharma, Inc.

Failed Dissolution Specifications.

July 9, 2025 · DrugView details →
Class IIOngoing

Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

Ascend Laboratories, LLC

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

July 9, 2025 · DrugView details →
Class IIOngoing

Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy

Boothwyn Pharmacy LLC

Subpotent Drug

July 9, 2025 · DrugView details →
Class IIOngoing

Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →
Class IIOngoing

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

July 7, 2025 · DrugView details →
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