Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 12, 2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalat... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis O... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Fre... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free,... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Prese... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversi... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake W... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Convers... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 W... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Pres... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free,... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhala... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuV... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhala... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 11, 2019 | Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, p... | Presence of Foreign Substance: Foreign material found inside the vial. | Class II | AuroMedics Pharma LLC |
| Nov 8, 2019 | Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively ... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X;... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India excl... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exc... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in Ind... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Cal... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 2... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 6, 2019 | GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-0... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Golden State Medical Supply Inc. |
| Nov 6, 2019 | DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... | Class II | AuroMedics Pharma LLC |
| Nov 6, 2019 | GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-0... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Golden State Medical Supply Inc. |
| Nov 6, 2019 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... | Class II | AuroMedics Pharma LLC |
| Nov 6, 2019 | Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... | Class II | AuroMedics Pharma LLC |
| Nov 6, 2019 | Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... | Class II | AuroMedics Pharma LLC |
| Nov 6, 2019 | Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed b... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... | Class II | AuroMedics Pharma LLC |
| Nov 4, 2019 | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... | Presence of foreign substance: Brown/black particles found during stability testing. | Class II | Teva Pharmaceuticals USA, Inc. |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.