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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Date	Product	Reason	Class	Firm
Aug 22, 2016	Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9...	Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)...	Class II	Noven Pharmaceuticals, Inc.
Aug 22, 2016	Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9...	Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)...	Class II	Noven Pharmaceuticals, Inc.
Aug 8, 2016	Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M...	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c...	Class II	Pharmatech LLC
Aug 8, 2016	Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160...	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c...	Class II	Pharmatech LLC
Aug 8, 2016	Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by:...	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c...	Class II	Pharmatech LLC
Aug 8, 2016	Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg i...	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c...	Class II	Pharmatech LLC
Aug 8, 2016	Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz...	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c...	Class II	Pharmatech LLC
Aug 8, 2016	Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bay...	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c...	Class II	Pharmatech LLC
Aug 8, 2016	Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. ...	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c...	Class II	Pharmatech LLC
May 26, 2016	Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz ...	Crystallization; Complaints that cream appears to have crystallized	Class III	Stratus Pharmaceuticals Inc
May 16, 2016	VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, ...	Defective delivery system: Softgel capsules are leaking.	Class III	Virtus Pharmaceuticals, Llc
May 13, 2016	Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottl...	Chemical Contamination: Bottles may contain broken dessicants	Class III	Virtus Pharmaceuticals, Llc
Apr 18, 2016	Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-...	Defective Container: Excess lidding material accumulation between the seal and the cup resulting ...	Class II	VistaPharm, Inc.
Apr 2, 2016	Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, ...	Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.	Class I	Complete Pharmacy and Medical Solutions LLC
Mar 31, 2016	LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufacture...	Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033	Class II	Invisiblu International LLC
Jan 18, 2016	Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24...	Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re...	Class III	Bausch & Lomb, Inc.
Jan 18, 2016	Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only...	Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re...	Class III	Bausch & Lomb, Inc.
Jan 18, 2016	Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL...	Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re...	Class III	Bausch & Lomb, Inc.
Jan 15, 2016	Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Suppleme...	Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could...	Class III	Virtus Pharmaceuticals, Llc
Dec 29, 2015	Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous adm...	Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.	Class I	Complete Pharmacy and Medical Solutions LLC
Dec 23, 2015	APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclus...	Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ...	Class I	Nuway Distributors, LLC
Dec 21, 2015	Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9...	Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)...	Class II	Noven Pharmaceuticals, Inc.
Dec 21, 2015	Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9...	Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)...	Class II	Noven Pharmaceuticals, Inc.
Dec 21, 2015	Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9...	Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)...	Class II	Noven Pharmaceuticals, Inc.
Dec 17, 2015	VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Suppl...	Defective Delivery System: Product may contain leaking capsules.	Class III	Virtus Pharmaceuticals, Llc
Nov 23, 2015	SUPER HERBS 350 mg, 30 capsules per bottle.	Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine ...	Class I	Super Herbs
Nov 6, 2015	Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol...	Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecal...	Class I	Glades Drugs Inc.
Sep 25, 2015	Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R...	Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.	Class II	Actavis Laboratories, FL, Inc.
Aug 27, 2015	MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules ...	Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosilden...	Class I	The One Minute Miracle Inc
Aug 27, 2015	MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The ...	Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphth...	Class I	The One Minute Miracle Inc
Aug 21, 2015	Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, pa...	Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling pr...	Class II	Nephron Pharmaceuticals Corp.
Aug 21, 2015	Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Race...	Discoloration	Class II	Nephron Pharmaceuticals Corp.
Aug 21, 2015	Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (...	Discoloration	Class II	Nephron Pharmaceuticals Corp.
Aug 17, 2015	Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured b...	Lack of Assurance of Sterility: Failed preservative effectiveness testing.	Class II	Bausch & Lomb, Inc.
Jul 27, 2015	Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3...	Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.	Class II	Noven Pharmaceuticals, Inc.
Jul 13, 2015	Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-coun...	Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desme...	Class I	Life and More LLC
Jul 2, 2015	Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distribute...	Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutr...	Class I	XTREME Z DISTRIBUTORS INC
Jun 26, 2015	METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactu...	Defective Container: Lids on unit dose cups are not fully qualified.	Class III	VistaPharm, Inc.
Jun 23, 2015	Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured...	Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.	Class III	Actavis Laboratories, FL, Inc.
Apr 24, 2015	Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. R...	Failed Stability Specifications: Product failed to meet 12 months long term stability specificati...	Class II	Romark Laboratories, L.C.
Apr 16, 2015	Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)	Products failed the Antimicrobial Effectiveness Test	Class II	Tarmac Products, Inc.
Apr 16, 2015	Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 ...	Products failed the Antimicrobial Effectiveness Test.	Class II	Tarmac Products, Inc.
Apr 16, 2015	Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle,	Products failed the Antimicrobial Effectiveness Test	Class II	Tarmac Products, Inc.
Mar 26, 2015	Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ...	Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ...	Class III	Actavis Laboratories, FL, Inc.
Mar 10, 2015	ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semil...	Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains u...	Class I	Ultra ZX Supplements
Feb 25, 2015	Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, M...	Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.	Class II	Noven Pharmaceuticals, Inc.
Feb 6, 2015	Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg...	Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-mo...	Class II	Tarmac Products, Inc.
Jan 20, 2015	Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, Am...	Non-Sterility: Product tested positive for bacterial contamination.	Class I	Pacifico National, Inc. dba AmEx Pharmacy
Jan 20, 2015	Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx ...	Non-Sterility: Product tested positive for bacterial contamination.	Class I	Pacifico National, Inc. dba AmEx Pharmacy
Jan 12, 2015	Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3...	Defective Delivery System: One lot exceeded the mechanical peel specification	Class II	Noven Pharmaceuticals, 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.