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Browse Drug Recalls

129 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 129 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 129 FDA drug recalls.

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DateProductReasonClassFirm
Sep 12, 2019 Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Us... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fi... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 10... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropic... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx On... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxin... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KR... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 2... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS G... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Sy... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global B... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechno... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Ca... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.01... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite F... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Sing... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Gl... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Us... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropic... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Sing... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx O... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Jan 16, 2019 NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 16, 2019 NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Bi... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechno... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of ... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Globa... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commer... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx On... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, R... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global B... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mes... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx O... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Onl... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only,... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Comm... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology,... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, ... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder pa... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, 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.