Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
Dec 20, 2019 BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 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 FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infu... 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 FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (71... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
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 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 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 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 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 TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 53... 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 HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 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 MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
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 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 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 53... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance I... 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 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 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (... 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 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance In... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 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
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-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-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-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-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-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-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-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 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-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-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-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-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-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

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.