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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
Sep 12, 2019 L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Gl... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 2... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), F... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized,... 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 L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG... CGMP Deviations: Received notice from supplier that there is potential glass contamination. Class II Spectrum Laboratory Products
Sep 12, 2019 Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Glo... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate 9 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 Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Sin... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartri... Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... Class I Shire Human Genetic Therapies, Inc.
Sep 12, 2019 Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injection... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Onl... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fi... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL S... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartri... Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... Class I Shire Human Genetic Therapies, Inc.
Sep 12, 2019 SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Par... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syr... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 12, 2019 ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fi... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnolog... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL)... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single D... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free)... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fi... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vi... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 1... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only,... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 10... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
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

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.