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

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
Jul 11, 2016 Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... Failed Dissolution Specifications Class II Actavis Inc
Jul 7, 2016 Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor He... CGMP Deviations Class II Safecor Health, LLC
Jul 7, 2016 Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health... CGMP Deviations Class II Safecor Health, LLC
Jul 7, 2016 Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Heal... CGMP Deviations Class II Safecor Health, LLC
Jul 7, 2016 Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor He... CGMP Deviations Class II Safecor Health, LLC
Jul 7, 2016 Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, ... CGMP Deviations Class II Safecor Health, LLC
Jul 7, 2016 Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W... Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile envir... Class II Medicap Pharmacy
Jul 7, 2016 Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count ... CGMP Deviations Class II Safecor Health, LLC
Jul 5, 2016 Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chlorid... Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant cl... Class II Let's Talk Health, Inc.
Jul 1, 2016 Dream Body 450 mg 30 capsules in a plastic screw on top bottle Marketed without an approved NDA/ANDA: Undeclared sibutramine. Class II Dream Body Weight Loss
Jul 1, 2016 Dream Body Advanced 400 mg 30 capsules in brown foil packets. Marketed without an approved NDA/ANDA: Undeclared sibutramine. Class II Dream Body Weight Loss
Jul 1, 2016 Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle Marketed without an approved NDA/ANDA: Undeclared sibutramine. Class II Dream Body Weight Loss
Jun 30, 2016 TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional ... Failed Content Uniformity Specifications Class II Allergan Sales, LLC
Jun 30, 2016 TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for O... Failed Content Uniformity Specifications Class II Allergan Sales, LLC
Jun 30, 2016 Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufact... Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... Class II Actavis Inc
Jun 29, 2016 TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial... Class II Vital Care Compounder, LLC
Jun 29, 2016 Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multi... Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action f... Class II Isomeric Pharmacy Solution, LLC
Jun 29, 2016 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5... Failed Stability Specifications: The recalled lots did not meet the specification for color and p... Class III Hospira Inc.
Jun 28, 2016 DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,... Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ... Class III Golden State Medical Supply Inc.
Jun 27, 2016 Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-c... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 t... Failed Dissolution Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-cou... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-c... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 24, 2016 Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Man... Superpotent drug: Out of specification test result for assay during stability testing. Class II Teva North America
Jun 23, 2016 Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake ... Crystallization: Product contains particulate identified to be crystallized active ingredient. Class II Hospira Inc.
Jun 22, 2016 Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Ma... Failed Dissolution Specifications Class II Mylan Pharmaceuticals Inc.
Jun 22, 2016 Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in ... Presence of Foreign Substance; presence of black particles describes generically as cellulose-bas... Class II Teva North America
Jun 20, 2016 Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY,... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 17, 2016 Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... CGMP Deviations Class II Teva North America
Jun 17, 2016 Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... CGMP Deviations Class II Teva North America
Jun 17, 2016 Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... CGMP Deviations Class II Teva North America
Jun 17, 2016 ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... CGMP Deviations Class II Teva North America
Jun 13, 2016 Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - ... Presence of Particulate Matter; The firm received two product complaints for small, dark particul... Class II Sagent Pharmaceuticals Inc
Jun 13, 2016 Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur... Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is print... Class III Jubilant Cadista Pharmaceuticals, Inc.
Jun 10, 2016 SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ... Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphy... Class III Valeant Pharmaceuticals North America LLC
Jun 7, 2016 Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in... Subpotency: product assayed and found OOS for cyproheptadine Class III Lyne Laboratories, Inc.
Jun 3, 2016 Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Redd... Failed impurities/degradation: out of specification result for impurity secorapamycin. Class III Dr. Reddy's Laboratories, Inc.
Jun 2, 2016 Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05)... Crystallization; complaints received by the manufacturer of crystals forming in product Class III Exact-Rx Inc
Jun 1, 2016 CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. ... Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. Class II Aidarex Pharmaceuticals LLC
Jun 1, 2016 Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, ... Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. Class III Aidarex Pharmaceuticals LLC
Jun 1, 2016 CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... Class III Aidarex Pharmaceuticals LLC
May 31, 2016 mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. Class III Teva North America
May 30, 2016 Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ... Class III Prinston Pharmaceutical Inc
May 28, 2016 Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 ... Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydro... Class III Par Pharmaceutical
May 26, 2016 Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz ... Crystallization; Complaints that cream appears to have crystallized Class III Stratus Pharmaceuticals 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.