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Browse Drug Recalls

1,528 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,528 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 1,528 FDA drug recalls in FL.

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DateProductReasonClassFirm
Apr 6, 2020 Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL b... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Mar 31, 2020 Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... Defective Delivery System: Out of specification for mechanical peel and shear. Class II Noven Therapeutics, LLC
Mar 31, 2020 Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... Defective Delivery System: Out of specification for mechanical peel and shear. Class II Noven Therapeutics, LLC
Mar 31, 2020 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Out of specification for mechanical peel and shear. Class II Noven Therapeutics, LLC
Mar 16, 2020 Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tam... Lack of Assurance of Sterility Class II The Medicine Shoppe Pharmacy
Mar 10, 2020 Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with c... Subpotent Drug Class II Matthew 7:25 Inc dba Thrive Pharmacy
Mar 10, 2020 Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with... Subpotent Drug Class II Matthew 7:25 Inc dba Thrive Pharmacy
Mar 10, 2020 Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with... Subpotent Drug Class II Matthew 7:25 Inc dba Thrive Pharmacy
Mar 2, 2020 Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 ... Defective Delivery System: Out of specification for mechanical peel and shear. Class II Noven Therapeutics, LLC
Mar 2, 2020 Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 ... Defective Delivery System: Out of specification for mechanical peel and shear. Class II Noven Therapeutics, LLC
Mar 2, 2020 Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 ... Defective Delivery System: Out of specification for mechanical peel and shear. Class II Noven Therapeutics, LLC
Mar 2, 2020 Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 ... Defective Delivery System: Out of specification for mechanical peel and shear. Class II Noven Therapeutics, LLC
Jan 31, 2020 Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed b... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Jan 31, 2020 Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Effici... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Jan 31, 2020 New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Oct 9, 2019 Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose ... Crystallization: Presence of particulate matter identified as API crystallization Class II Ingenus Pharmaceuticals Llc
Sep 23, 2019 DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 23, 2019 DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 16, 2019 Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2... Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Class I FITOTERAPIA USA, INC
Sep 12, 2019 LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 m... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Human Chorionic Gonadotropin 5,000 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% (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 Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx... 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, 8 mg/250 mL (0.03... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
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 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 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

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.