DrugJul 8, 2015
Lincare TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10% recall — FDA D-1157-2015
Lack of Assurance of Sterility: Sterility of product is not assured.
Class IIFDA: TerminatedLincare, Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 300
10,690 detailed records are currently available in this category.
DrugJul 8, 2015
Lincare Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag recall — FDA D-1203-2015
Lack of Assurance of Sterility: Sterility of product is not assured.
Class IIFDA: TerminatedLincare, Inc.
DrugJul 1, 2015
Indiana Botanic Gardens Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of recall — FDA D-1149-2015
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Class IIIFDA: TerminatedIndiana Botanic Gardens, Inc.
DrugJul 1, 2015
Bracco Diagnostic E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil recall — FDA D-1147-2015
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class IIIFDA: TerminatedBracco Diagnostic Inc.
DrugJul 1, 2015
Actavis Lutera recall — FDA D-1148-2015
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Class IIIFDA: TerminatedActavis Inc.
DrugJun 24, 2015
AstraZeneca Pharmaceuticals NEXIUM (esomeprazole magnesium), Delayed-Release capsules, 20 recall — FDA D-1141-2015
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM capsules contained 60 SEROQUEL XR tablets.
Class IIFDA: TerminatedAstraZeneca Pharmaceuticals LP
DrugJun 24, 2015
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) recall — FDA D-1139-2015
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Class IIIFDA: TerminatedWest-Ward Pharmaceutical Corp.
DrugJun 24, 2015
Ohm Laboratories Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy recall — FDA D-1142-2015
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
DrugJun 24, 2015
Novartis Pharmaceuticals Foradil Aerolizer recall — FDA D-1138-2015
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class IIIFDA: TerminatedNovartis Pharmaceuticals Corp.
DrugJun 24, 2015
Allegiant Health Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and recall — FDA D-1134-2015
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Class IIFDA: TerminatedAllegiant Health
DrugJun 24, 2015
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count recall — FDA D-1135-2015
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugJun 24, 2015
Novartis Pharmaceuticals Foradil Aerolizer recall — FDA D-1137-2015
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class IIIFDA: TerminatedNovartis Pharmaceuticals Corp.
DrugJun 17, 2015
SCA Pharmaceuticals PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag recall — FDA D-1133-2015
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
Class IIFDA: TerminatedSCA Pharmaceuticals
DrugJun 17, 2015
Valeant Pharmaceuticals Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles recall — FDA D-1116-2015
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Class IIFDA: TerminatedValeant Pharmaceuticals North America LLC
DrugJun 17, 2015
MD GASTROVIEW MD-Gastroview recall — FDA D-1132-2015
Labeling: incorrect or missing lot number and/or expiration date
Class IIFDA: TerminatedMallinckrodt, Inc.
DrugJun 10, 2015
Medtech Products SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist recall — FDA D-1113-2015
Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry…
Class IIFDA: TerminatedMedtech Products, Inc.
DrugJun 10, 2015
Sandoz Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) recall — FDA D-1115-2015
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Class IIIFDA: TerminatedSandoz, Inc.
DrugJun 10, 2015
Teva Pharmaceuticals USA Zebeta (bisoprolol fumarate), tablets, 10mg, 30-count bottle recall — FDA D-1112-2015
Failed Dissolution Specifications: OOS result during stability testing
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugJun 10, 2015
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and recall — FDA D-1114-2015
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Class IIFDA: TerminatedFresenius Kabi USA, LLC
DrugJun 3, 2015
Daytrana recall — FDA D-1086-2015
Defective Delivery System: One lot exceeded the mechanical peel specification
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugJun 3, 2015
Hospira LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag recall — FDA D-1108-2015
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Class IFDA: TerminatedHospira Inc.
DrugJun 3, 2015
Blenheim Pharmacal Captopril Tablets, USP, 50 mg, 30 Tablets recall — FDA D-1109-2015
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market…
Class IIFDA: TerminatedBlenheim Pharmacal, Inc.
DrugJun 3, 2015
Teva Pharmaceuticals USA QVAR recall — FDA D-1087-2015
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugJun 3, 2015
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles recall — FDA D-1085-2015
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Class IIFDA: CompletedBoehringer Ingelheim Roxane 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.