Browse Drug Recalls
23 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 23 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 23 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 24, 2024 | EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical A... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Jan 30, 2024 | Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Nov 13, 2023 | EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% a... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Jun 13, 2023 | Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... | Class II | K.C. Pharmaceuticals, Inc |
| Nov 21, 2022 | Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... | CGMP Deviations | Class II | Vi-Jon, LLC |
| May 24, 2022 | Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles,... | Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofen... | Class I | Walmart Inc |
| May 24, 2022 | Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottl... | Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... | Class II | Walmart Inc |
| May 24, 2022 | Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bo... | Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... | Class II | Walmart Inc |
| Jan 4, 2022 | equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| 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 | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 ... | 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 |
| Jun 16, 2021 | Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottl... | cGMP deviations: Discolored acetaminophen | Class II | Spirit Pharmaceuticals |
| Nov 17, 2020 | Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) ... | Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Jul 2, 2019 | Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Pa... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25... | Lack of Assurance of Sterility | Class II | Altaire 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.