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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

858 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 858 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 858 FDA drug recalls in NC.

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DateProductReasonClassFirm
Aug 6, 2020 Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharm... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 m... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy ... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Jun 23, 2020 Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bott... cGMP deviations: one lot of the product was distributed to US Markets despite being rejected duri... Class III Biogen MA Inc.
May 5, 2020 Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, R... Short Fill Class III Exela Pharma Sciences LLC
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 19, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... Microbial contamination of non-sterile products: positive test for yeast and bacteria. Class II Filltech USA, LLC
Mar 2, 2020 Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayn... Product Mix-Up: A foreign tablet was found in bottle. Class II Mayne Pharma Inc
May 31, 2019 ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
May 31, 2019 Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Go... Lack of sterility assurance. Class II CMC Enterprise Pharmacy
Feb 22, 2019 Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per pac... Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutrami... Class I Golean Detox US
Oct 26, 2018 deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl.... CGMP Deviations: Product was released to market prior to microbiological testing. Class II S.C. Johnson Professional
Oct 26, 2018 Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8... CGMP Deviations: Product was released to market prior to microbiological testing. Class II S.C. Johnson Professional
Aug 21, 2018 Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufact... Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets US... Class I Accord Healthcare, Inc.
Aug 21, 2018 Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx ... Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary cont... Class III Mayne 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.