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 |
|---|---|---|---|---|
| Oct 18, 2019 | BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 m... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg ... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 17, 2019 | AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 4229... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AVKARE Inc. |
| Oct 17, 2019 | AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 4229... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AVKARE Inc. |
| Oct 15, 2019 | Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpora... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpora... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio I... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporate... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpo... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio ... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 10, 2019 | Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: I... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 10, 2019 | Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, ... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 10, 2019 | Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx On... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 10, 2019 | Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx On... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| Oct 9, 2019 | Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose ... | Crystallization: Presence of particulate matter identified as API crystallization | Class II | Ingenus Pharmaceuticals Llc |
| Oct 9, 2019 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysi... | Lack of Assurance of Sterility; bags have potential to leak | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 9, 2019 | PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chlorid... | GMP Deviations: potential glass contamination | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 9, 2019 | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chlo... | GMP Deviations: potential glass contamination | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 9, 2019 | del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephr... | Lack of Assurance of Sterility; bags have potential to leak | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 9, 2019 | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride ... | GMP Deviations: potential glass contamination | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 7, 2019 | Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan I... | Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity resu... | Class II | Mylan Laboratories Limited (Sterile Products Di... |
| Oct 2, 2019 | 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 ... | Lack of Assurance of Sterility: Bag has the potential to leak. | Class II | Pfizer Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 1... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count b... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC. | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger) | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) ... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) ... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) ... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OT... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) ... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, 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.