Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 20, 2019 | HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 5... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe A... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713)... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) ... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Nov 19, 2019 | 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare... | Lack of Assurance of Sterility: Product has the potential to leak. | Class II | Baxter Healthcare Corporation |
| 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-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-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-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-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 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 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 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 5,500 USP Units For injection, Rx On... | Lack of Sterility Assurance. | Class II | Innoveix Pharmaceuticals Inc |
| 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 | 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 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 | Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injectio... | Lack of sterility assurance. | Class II | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy |
| Sep 20, 2019 | Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx ... | Lack of Assurance of Sterility: Out of specification results for container closure test which can... | Class II | Akorn, 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.