Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 17, 2018 | Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06)... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 15, 2018 | Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,... | Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle | Class II | Heritage Pharmaceuticals, Inc. |
| Oct 15, 2018 | Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sa... | Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine | Class II | Zero Xtreme USA |
| Oct 15, 2018 | Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile si... | Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the imp... | Class III | Baxter Healthcare Corporation |
| Oct 11, 2018 | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP... | CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for... | Class II | Lannett Company, Inc. |
| Oct 9, 2018 | SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by S... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactur... | Defective Container: Repetitive complaints received indicating pump not working. | Class III | Lupin Pharmaceuticals Inc. |
| Oct 9, 2018 | MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 8, 2018 | 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15... | Lack of Assurance of Sterility; bags have the potential to leak | Class II | ICU Medical Inc |
| Oct 8, 2018 | 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC... | Lack of Assurance of Sterility; bags have the potential to leak | Class II | ICU Medical Inc |
| Oct 8, 2018 | Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Onl... | Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. | Class II | Akorn, Inc. |
| Oct 5, 2018 | Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90... | Container packaging defect. | Class III | Orexigen Therapeutics, Inc. |
| Oct 5, 2018 | Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured... | Failed Impurities/Degradation Specifications:Out of specification result noticed for total impuri... | Class II | LUPIN SOMERSET |
| Oct 5, 2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... | Class III | Amerigen Pharmaceuticals Inc. |
| Oct 3, 2018 | Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed ... | Microbial Contamination of Non-Sterile Products | Class I | Silver Star Brands |
| Oct 3, 2018 | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... | Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... | Class III | InvaGen Pharmaceuticals, Inc. |
| Oct 3, 2018 | Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed ... | Microbial Contamination of Non-Sterile Products | Class I | Silver Star Brands |
| Oct 3, 2018 | Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... | Microbial Contamination of Non-Sterile Product | Class I | Silver Star Brands |
| Oct 3, 2018 | Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Silver Star Brands |
| Oct 3, 2018 | Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g T... | Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Hep... | Class II | Pfizer Inc. |
| Oct 3, 2018 | Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, ... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Silver Star Brands |
| Oct 3, 2018 | Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed... | Microbial Contamination of Non-Sterile Products | Class I | Silver Star Brands |
| Oct 2, 2018 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... | Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Sep 28, 2018 | Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Su... | Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration dat... | Class II | Tailor Made Compounding |
| Sep 27, 2018 | Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class II | Teva Pharmaceuticals USA |
| Sep 26, 2018 | Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per... | CGMP deviations | Class II | GLAXOSMITHKLINE NEBRASKA |
| Sep 25, 2018 | Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top p... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, Inc. |
| Sep 25, 2018 | Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, Inc. |
| Sep 25, 2018 | Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx ... | Subpotent drug: During testing of the retention sample, the firm discovered that the product was ... | Class II | RXQ Compounding LLC |
| Sep 25, 2018 | Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pi... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, 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.