Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 6, 2021 | Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Singl... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single D... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, ... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% /... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Ph... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),... | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... | Class II | Medique Products |
| Dec 6, 2021 | Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Nov 29, 2021 | PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... | CGMP Deviations: failed stability results, inadequate laboratory investigations, | Class II | ULTRAtab Laboratories, Inc. |
| Nov 23, 2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deod... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, To... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Ant... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, C... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash ... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chl... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, ... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Pro... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Esse... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 1, 2021 | Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Ind... | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Class II | Precision Dose Inc. |
| Nov 1, 2021 | Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup... | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Class II | Precision Dose Inc. |
| Oct 26, 2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL O... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... | CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t... | Class II | VIRGIN SCENT INC |
| Oct 26, 2021 | Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
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.