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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 13, 2014 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re... | Class II | Noven Pharmaceuticals, Inc. |
| Jan 31, 2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oi... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 ... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical O... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only ... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. ... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), ... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx ... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 31, 2014 | SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), ... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Jan 24, 2014 | Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Anoth... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs,... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, dist... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distribu... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, dis... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-d... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by My... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cang... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed ... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, suppl... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Jan 24, 2014 | Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKn... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceuti... | Class I | MyNicNaxs, Inc. |
| Dec 20, 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... | Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. | Class II | Watson Laboratories, Inc.-(Actavis) - Florida |
| Nov 4, 2013 | Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45... | Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclare... | Class I | IQ Formulations, LLC |
| Oct 15, 2013 | Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administ... | Defective Container: A lidding deformity allowed for the product to have out of specification res... | Class II | VistaPharm, Inc. |
| Oct 7, 2013 | Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules. | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | Class I | B @ B Trade Inc. |
| Oct 7, 2013 | Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgel... | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | Class I | B @ B Trade Inc. |
| Oct 7, 2013 | Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules. | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | Class I | B @ B Trade Inc. |
| Oct 2, 2013 | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalatio... | Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic ... | Class II | Nephron Pharmaceuticals Corp. |
| Sep 8, 2013 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Sep 8, 2013 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Aug 21, 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... | Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2... | Class III | Actavis South Atlantic LLC |
| Aug 14, 2013 | Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet She... | Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil | Class I | Fabscout Entertainment, Inc |
| Aug 14, 2013 | PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsu... | Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil | Class I | Fabscout Entertainment, Inc |
| Aug 14, 2013 | 72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in... | Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil | Class I | Fabscout Entertainment, Inc |
| Aug 12, 2013 | J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 ho... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Jack Rabbit, Inc |
| Jul 4, 2013 | Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Onl... | Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. | Class II | VistaPharm, Inc. |
| Jun 27, 2013 | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Fabscout Entertainment, Inc |
| Jun 27, 2013 | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 1... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Fabscout Entertainment, Inc |
| May 29, 2013 | Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 2... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmac... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 29, 2013 | Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection, compounded by Olymp... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
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.