DrugOct 30, 2013
Hi-Tech Pharmacal Co GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. recall — FDA D-66207-001
Subpotent; phenylephrine HCl
Class IIIFDA: TerminatedHi-Tech Pharmacal Co., Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 402
10,690 detailed records are currently available in this category.
DrugOct 23, 2013
Mcneil Consumer Healthcare, Div Of Mcneil-ppc Concentrated Motrin (ibuprofen) Infants' Drops recall — FDA D-66272-001
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Class IIFDA: TerminatedMcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
DrugOct 16, 2013
Sandoz Hydroxychloroquine Sulfate Tablets, USP, 200 mg recall — FDA D-66373-001
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Class IIIFDA: TerminatedSandoz Inc.
DrugOct 9, 2013
AmeriSource Bergen Ifosfamide Injection 3g/60 mL, Single dose vial recall — FDA D-1066-2013
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Class IIFDA: TerminatedAmeriSource Bergen
DrugOct 9, 2013
Osmotica Pharmaceutical Venlafaxine recall — FDA D-1067-2013
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Class IIIFDA: TerminatedOsmotica Pharmaceutical Corp
DrugOct 9, 2013
Triangle Compounding Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium recall — FDA D-1068-2013
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedTriangle Compounding
DrugOct 9, 2013
Triangle Compounding Histamine, 10 ng/mL Injectable, MDV recall — FDA D-1069-2013
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedTriangle Compounding
DrugOct 9, 2013
Watson Laboratories Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count recall — FDA D-66251-001
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Class IIFDA: TerminatedWatson Laboratories Inc.
DrugOct 9, 2013
Marlex Pharmaceuticals Acetaminophen Tablets, 500 mg, 100-count bottles recall — FDA D-1064-2013
CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
Class IIFDA: TerminatedMarlex Pharmaceuticals, Inc.
DrugOct 9, 2013
AmeriSource Bergen Ifosfamide Injection 1g/20mL, Single dose vial recall — FDA D-1065-2013
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Class IIFDA: TerminatedAmeriSource Bergen
DrugOct 2, 2013
Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL recall — FDA D-1063-2013
Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty…
Class IIFDA: TerminatedWalgreens Co
DrugOct 2, 2013
Core Pharma Pyridostigmine Bromide Tablets 60 mg, USP recall — FDA D-1062-2013
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Class IIFDA: TerminatedCore Pharma LLC
DrugSep 25, 2013
JCB Labs Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative recall — FDA D-1047-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedJCB Labs LLC
DrugSep 25, 2013
Northern New England Compounding Pharmacy Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj. recall — FDA D-1060-2013
Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility…
Class IIFDA: TerminatedNorthern New England Compounding Pharmacy LLC
DrugSep 25, 2013
Leiter's Pharmacy Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial recall — FDA D-1041-2013
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were…
Class IIFDA: TerminatedLeiter's Pharmacy
DrugSep 25, 2013
Leiter's Pharmacy Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose recall — FDA D-1038-2013
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported…
Class IIFDA: TerminatedLeiter's Pharmacy
DrugSep 25, 2013
JCB Labs Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection recall — FDA D-1044-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedJCB Labs LLC
DrugSep 25, 2013
IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) recall — FDA D-1042-2013
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugSep 25, 2013
JCB Labs Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not recall — FDA D-1043-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedJCB Labs LLC
DrugSep 25, 2013
Medaus Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 recall — FDA D-1053-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedMedaus, Inc.
DrugSep 25, 2013
SPIRIVA HandiHaler recall — FDA D-1057-2013
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Class IIIFDA: TerminatedBoehringer Ingelheim Roxane Inc.
DrugSep 25, 2013
Medaus Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 recall — FDA D-1050-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedMedaus, Inc.
DrugSep 25, 2013
JCB Labs Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL recall — FDA D-1045-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedJCB Labs LLC
DrugSep 25, 2013
Medaus Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183 recall — FDA D-1052-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results…
Class IIFDA: TerminatedMedaus, Inc.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.