DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML recall — FDA D-0973-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
10,685drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 151
10,685 detailed records are currently available in this category.
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* recall — FDA D-0974-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Methylprednisolone Acetate Injectable Suspension recall — FDA D-0972-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle recall — FDA D-0862-2020
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable recall — FDA D-0944-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Triamcinolone Diacetate Injectable Suspension recall — FDA D-0989-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML recall — FDA D-0967-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Nicotinamide Adenine Dinucleotide (PF) Injection recall — FDA D-0977-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 4, 2020
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) recall — FDA D-0863-2020
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Class IFDA: TerminatedTaro Pharmaceuticals U.S.A., Inc.
DrugMar 4, 2020
Akorn Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes recall — FDA D-0860-2020
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the…
Class IIIFDA: TerminatedAkorn, Inc.
DrugMar 4, 2020
Akorn CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes recall — FDA D-0861-2020
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the…
Class IIIFDA: TerminatedAkorn, Inc.
DrugMar 4, 2020
Golden State Medical Supply TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg recall — FDA D-0856-2020
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored…
Class IIIFDA: TerminatedGolden State Medical Supply Inc.
DrugMar 4, 2020
Akorn Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes recall — FDA D-0859-2020
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the…
Class IIIFDA: TerminatedAkorn, Inc.
DrugMar 4, 2020
Breckenridge Pharmaceutical Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for recall — FDA D-1063-2020
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Class IIIFDA: TerminatedBreckenridge Pharmaceutical, Inc.
DrugFeb 26, 2020
American Health Packaging Desmopressin Acetate Tablets, 0.1 mg, 30 tablets recall — FDA D-0848-2020
GMP Deviations: Product bottle may be absent of desiccant.
Class IIFDA: TerminatedAmerican Health Packaging
DrugFeb 26, 2020
American Health Packaging Desmopressin Acetate Tablets, 0.2 mg, 30 tablets recall — FDA D-0849-2020
GMP Deviations: Product bottle may be absent of desiccant.
Class IIFDA: TerminatedAmerican Health Packaging
DrugFeb 26, 2020
Teva Pharmaceuticals USA Tramadol Hydrochloride Tablets USP CIV, 50 mg recall — FDA D-0851-2020
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored…
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugFeb 26, 2020
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial recall — FDA D-0853-2020
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class IIIFDA: TerminatedAuroMedics Pharma LLC
DrugFeb 26, 2020
Memantine Hydrochloride Extended-release Capsules, 28mg recall — FDA D-0844-2020
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugFeb 19, 2020
ACETAMINOPHEN Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer recall — FDA D-0858-2020
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count…
Class IIFDA: TerminatedContract Pharmacal Corporation
DrugFeb 19, 2020
Lamotrigine Tablets, USP, 100 mg recall — FDA D-0833-2020
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class IFDA: TerminatedTaro Pharmaceuticals U.S.A., Inc.
DrugFeb 19, 2020
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles recall — FDA D-0855-2020
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugFeb 19, 2020
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles recall — FDA D-0852-2020
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugFeb 19, 2020
Contract Pharmacal Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever recall — FDA D-0857-2020
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count…
Class IIFDA: TerminatedContract Pharmacal Corporation
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.