Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Drug Recalls

515 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 515 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 515 FDA drug recalls.

Clear
DateProductReasonClassFirm
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 11, 2019 Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Oct 25, 2019 LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical Inc
Oct 25, 2019 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... Presence of Particulate Matter. Class I ICU Medical 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
Sep 17, 2019 Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufac... cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tub... Class II Akorn, Inc.
Jun 28, 2019 Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 ... Presence of Particulate Matter; glass particulates Class I Fresenius Kabi USA, LLC
Apr 30, 2019 Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Onl... Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product Class I Par Pharmaceutical, Inc.
Mar 28, 2019 Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, M... Presence of Particulate Matter: One vial was found to contain a hair. Class I Aurobindo Pharma USA Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 15, 2019 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL)... Presence of Particulate Matter; glass particulates Class I Pfizer Inc.
Feb 14, 2019 Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL... Presence of Particulate Matter: Particulates observed in vials release for dispensing. Class II McGuff Compounding Pharmacy Services, Inc.
Feb 1, 2019 Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx... Presence of Particulate Matter: particulate matter identified as copper salts Class I Mylan Institutional Inc
Jan 10, 2019 Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 m... Presence of Particulate Matter: filmy/cloudy particulate observed in vial. Class II McGuff Compounding Pharmacy Services, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL ... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Dec 20, 2018 OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic ap... GMP Deviations: A silicone particulate was noted in Ozurdex. Class II Allergan, PLC.
Dec 20, 2018 Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 6818... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 6... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Oct 18, 2018 GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg... Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 mont... Class II H J Harkins Company Inc dba Pharma Pac
Oct 8, 2018 Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Onl... Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. Class II Akorn, Inc.
Aug 23, 2018 Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a phy... Class II Pacific Compounding Pharmacy & Consultations 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.