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.

DateProductReasonClassFirm
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.