Browse Drug Recalls

837 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 837 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 837 FDA drug recalls in NC.

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DateProductReasonClassFirm
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
Aug 14, 2018 Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) I... Defective Delivery System: Water ingress through the lower water cup sensor of the device. Class III United Therapeutics Corp.
Jul 20, 2018 Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsid... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 We... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc.... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Climate Adaptation Cold & Damp, 2 fl.... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Heavy Metal Detox, 2 fl. oz. (59 mL),... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx No Sweat/Anti-Perspirant, 2 fl. oz. (59 mL), King Bio,... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic For... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 West... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Total Body Detox Cleansing & Detox, 2 fl. oz. (59 mL),... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Urinary Tract Irritations, 2 fl. oz. ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 People's Best Arnica Gel Homeopathic Medicine Pain Relief, Net Wt. 2.6 oz (73... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Gossipy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Sugar Metabolizer Men/Women, 2 fl. oz. (59 mL), King B... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #11 (Lilac Label) Homeopathic Preparation, Oral Liquid, 57 mL, M... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #12 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: K... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Eye Stress, 2 fl. oz. (59 mL), King B... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Arthritis Pain & Joint Relief, 2 fl. ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Constipation Relief, 2 fl. oz. (59 mL... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx ApoPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside... Microbial contamination Class I King Bio 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.