Browse Drug Recalls
6,322 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,322 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 6,322 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 20, 2019 | FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (7... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 5... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (7... | 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 | BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syring... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Inf... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance I... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 3 mg/MORP 15 mg/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 | Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-... | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
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.