Drug Recalls — FDA Recall Database

10,685drug recall records

953FDA Class I records

8firms with 5+ records

Aidapak Services, LLC537 records

Database records

Records — page 156

10,685 detailed records are currently available in this category.

DrugDec 11, 2019

QuVa Pharma fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe recall — FDA D-0572-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) recall — FDA D-0564-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

Fagron LETS GEL KIT Convenience Pack recall — FDA D-0533-2020

Microbial contamination of non-sterile product.

Class IIFDA: TerminatedFagron, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) recall — FDA D-0565-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) recall — FDA D-0562-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL recall — FDA D-0547-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free recall — FDA D-0555-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL recall — FDA D-0550-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

Sanofi-Aventis U.S Maximum Strength Zantac 150 mg recall — FDA D-0539-2020

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIFDA: OngoingSanofi-Aventis U.S. LLC

DrugDec 11, 2019

QuVa Pharma fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free recall — FDA D-0566-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA recall — FDA D-0560-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag recall — FDA D-0553-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) recall — FDA D-0559-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD recall — FDA D-0571-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free recall — FDA D-0551-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) recall — FDA D-0552-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) recall — FDA D-0554-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL recall — FDA D-0557-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) recall — FDA D-0546-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA recall — FDA D-0570-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 11, 2019

QuVa Pharma fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL recall — FDA D-0549-2020

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Class IIFDA: TerminatedQuVa Pharma, Inc.

DrugDec 4, 2019

Avantor Performance Materials Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial recall — FDA D-0575-2020

Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.

Class IIFDA: TerminatedAvantor Performance Materials Inc.

DrugDec 4, 2019

AuroMedics Pharma Ranitidine Syrup recall — FDA D-0529-2020

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIFDA: OngoingAuroMedics Pharma LLC

DrugDec 4, 2019

AVKARE Ranitidine Tablets, USP 150 mg recall — FDA D-0524-2020

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIFDA: TerminatedAVKARE 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.

Drug Recalls in the United States

Records — page 156

How to use this drug recall index

What the database can and cannot tell you