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

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
Apr 22, 2019 Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by... Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substan... Class III Zydus Pharmaceuticals USA Inc
Apr 22, 2019 ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium ch... CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... Class II Inopak Ltd
Apr 22, 2019 Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II RemedyRepack Inc.
Apr 19, 2019 FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx... Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 ... Class I Alvogen, Inc
Apr 19, 2019 BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biol... Defective Delivery System: difficult to express Class II Pacifico National, Inc. dba AmEx Pharmacy
Apr 18, 2019 Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Apr 18, 2019 Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)10... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Apr 18, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-c... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Apr 18, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-co... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Apr 18, 2019 Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)10... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Apr 18, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Apr 15, 2019 Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ... Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterili... Class II Iso-Tex Diagnostics, Inc
Apr 12, 2019 Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Go... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: En... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 G... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL ... Subpotent Product: assay results for Amoxicillin were below the specification limits. Class II Teva Pharmaceuticals USA
Apr 12, 2019 Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use On... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 44... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy,... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Ph... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Us... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 G... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 44... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Ent... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 440... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Gol... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterpris... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Ph... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: En... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 12, 2019 Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Apr 11, 2019 Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (... cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. Class II Dr. Reddy's Laboratories, Inc.
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET

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.