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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
May 21, 2012 PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 DIFFERENT ... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 NADH-FFC 10 MG/CC INJECTABLE 10 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODU... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMC... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYP... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MAN... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE H... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 21, 2012 TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCI... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28m... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.
Apr 21, 2012 X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distri... Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hyd... Class I XRock Industries, LLC
Apr 5, 2012 Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured ... Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a ... Class II Apotex Corp.
Mar 22, 2012 Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 ho... Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel forc... Class II Noven Pharmaceuticals, Inc.
Nov 10, 2011 Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper ra... Misbranded Class II Victus, Inc.
Sep 30, 2011 Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dos... Defective container; lidding deformity allows the contained product to transpire causing potentia... Class II VistaPharm, Inc.
Jul 6, 2011 Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottl... Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulos... Class II Bausch & Lomb, Inc.
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jun 22, 2011 Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose ... Lack of Assurance of Sterility Class II Nephron Pharmaceuticals Corp.
Jun 15, 2011 Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metere... CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. Class III Apotex Corp.
Apr 6, 2011 Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit d... Defective container; lidding deformity allows the contained product to transpire causing potentia... Class II VistaPharm, Inc.
Jan 19, 2011 METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only... Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," inste... Class III VistaPharm, Inc.
Jun 14, 2007 Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apot... Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Class II Apotex Corp.
Jun 14, 2007 Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-co... Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Class II Apotex Corp.

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.