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 Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations 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 Brand History Cross-category recall lookup by company
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

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

Clear
DateProductReasonClassFirm
Feb 2, 2016 Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection ... Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect exp... Class III Hospira Inc.
Feb 2, 2016 Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial... Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrec... Class III Isomeric Pharmacy Solution, LLC
Jan 28, 2016 Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by M... Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 27, 2016 Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Jan 27, 2016 Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl ... Marketed without an approved NDA/ANDA Class II Bonita Pharmaceuticals, LLC
Jan 27, 2016 Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Jan 27, 2016 Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Jan 27, 2016 Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only... Failed Impurities/Degradation Specifications Class III Golden State Medical Supply Inc.
Jan 26, 2016 Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, M... Failed Dissolution Specification: Out of specification dissolution results when testing product s... Class III Apotex Scientific, Inc
Jan 26, 2016 Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Di... Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) Class III Amerisource Health Services
Jan 26, 2016 Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, M... Failed Dissolution Specification: Out of specification dissolution results when testing product s... Class III Apotex Scientific, Inc
Jan 26, 2016 Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, M... Failed Dissolution Specification: Out of specification dissolution results when testing product s... Class III Apotex Scientific, Inc
Jan 21, 2016 Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Singl... Presence of Particulate Matter: identified as a cloth fiber. Class I Baxter Healthcare Corp.
Jan 21, 2016 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... Presence of Particulate Matter: identified as cardboard. Class I Baxter Healthcare Corp.
Jan 21, 2016 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of ste... Class II Baxter Healthcare Corp.
Jan 21, 2016 CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose... Presence of Particulate Matter: identified as dried skin. Class I Baxter Healthcare Corp.
Jan 18, 2016 Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL... Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... Class III Bausch & Lomb, Inc.
Jan 18, 2016 Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only... Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... Class III Bausch & Lomb, Inc.
Jan 18, 2016 Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister car... Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. Class II Amerisource Health Services
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrig... Labeling: label error on declared strength. Class II Perrigo Company PLC
Jan 18, 2016 Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24... Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... Class III Bausch & Lomb, Inc.
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perri... Labeling: label error on declared strength. Class II Perrigo Company PLC
Jan 15, 2016 progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room tempe... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx i... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit s... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, T... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit siz... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size,... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manuf... Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. Class I Master Herbs, Inc./Li
Jan 15, 2016 Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abb... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Comp... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size,... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Suppleme... Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could... Class III Virtus Pharmaceuticals, Llc
Jan 15, 2016 papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compou... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx i... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, 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.