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Browse Drug Recalls

37 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 37 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 37 FDA drug recalls.

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DateProductReasonClassFirm
Oct 10, 2025 R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Trometha... Presence of Particulate Matter Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Sep 20, 2022 oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injec... Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride ... Class III QuVa Pharma, Inc.
May 28, 2020 oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Inject... Subpotent drug - Product did not contain drug. Class II QuVa Pharma, Inc.
Apr 23, 2020 R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride ... Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac Class III QuVa Pharma, Inc.
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 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 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 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 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 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 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 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 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 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 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 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 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 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/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 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 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 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 fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 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 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Pres... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1... 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) ROPivacaine HCl 0.2% 200 mg/100 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 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preser... 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) ROPivacaine HCl 0.2% 200 mg/100 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 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Ph... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, 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 fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Pre... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 21, 2018 Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 m... Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium C... Class III QuVa Pharma, Inc.
Aug 27, 2018 Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative ... Subpotent Drug: Product may not have the active ingredient present in the bag. Class I QuVa Pharma, Inc.
Mar 30, 2016 PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,... Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case... Class I QuVa Pharma, 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.