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 |
|---|---|---|---|---|
| May 21, 2021 | DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx ... | Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. | Class II | Hill Dermaceuticals, Inc. |
| May 20, 2021 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... | Defective Delivery System: The number of customer complaints for ripping patches and tight releas... | Class II | Noven Pharmaceuticals Inc |
| May 20, 2021 | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... | Defective Delivery System: The number of customer complaints for ripping patches and tight releas... | Class II | Noven Pharmaceuticals Inc |
| May 11, 2021 | Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Pos... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalaf... | Class I | Yamtun7 |
| Apr 27, 2021 | SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topi... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile To... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile T... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net W... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Top... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.3... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 16, 2021 | Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box... | Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... | Class II | Noven Pharmaceuticals Inc |
| Apr 16, 2021 | Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, ... | Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... | Class II | Noven Pharmaceuticals Inc |
| Mar 31, 2021 | Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufact... | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiap... | Class II | Apotex Corp. |
| Mar 10, 2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, liste... | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... | Class I | Sanit Technologies, LLC dba Durisan |
| Mar 10, 2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes... | CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the sa... | Class II | Sanit Technologies, LLC dba Durisan |
| Mar 10, 2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, liste... | CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the sa... | Class II | Sanit Technologies, LLC dba Durisan |
| Mar 10, 2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes... | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... | Class I | Sanit Technologies, LLC dba Durisan |
| Feb 19, 2021 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... | Defective Delivery System: Out of specification for mechanical peel. | Class II | Noven Pharmaceuticals Inc |
| Feb 19, 2021 | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... | Defective Delivery System: Out of specification for mechanical peel. | Class II | Noven Pharmaceuticals Inc |
| Feb 19, 2021 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... | Defective Delivery System: Out of specification for mechanical peel. | Class II | Noven Pharmaceuticals Inc |
| Feb 19, 2021 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... | Defective Delivery System: Out of specification for mechanical peel. | Class II | Noven Pharmaceuticals Inc |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut... | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 m... | Class I | Apotex Corp. |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati... | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 12... | Class I | Apotex Corp. |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodi... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodi... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sod... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodi... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 11, 2020 | Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | Apotex Corp. |
| Sep 25, 2020 | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v... | Failed Impurties/Degradation Specifications: out of specification results for an impurity for one... | Class III | VistaPharm, Inc. |
| Sep 3, 2020 | bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle... | CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed... | Class II | AJR TRADING LLC |
| Jun 23, 2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl... | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... | Class III | VistaPharm, Inc. |
| Jun 23, 2020 | Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only,... | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... | Class III | VistaPharm, Inc. |
| Jun 1, 2020 | Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL... | Subpotent Drug: Product was found to be subpotent. Product also has high pH levels | Class II | WORLD EVENT PROMOTIONS, LLC |
| Apr 15, 2020 | KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By ... | Chemical Contamination; product contains elevated levels of lead | Class I | Summitt Labs |
| Apr 6, 2020 | Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tub... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shopp... | Lack of Processing Control | Class II | The Medicine Shoppe 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.