Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 21, 2018 Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, ... Failed stability specifications - An out of specification result was observed for the test parame... Class II Dr. Reddy's Laboratories, Inc.
Sep 21, 2018 Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,... Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du... Class II Teva Pharmaceuticals USA
Sep 20, 2018 Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only... Failed Stability Specifications: Out-of-specification test result for water content obtained duri... Class II Teva Pharmaceuticals USA
Sep 20, 2018 Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Steril... Lack of assurance of sterility: loss of container integrity. Class II Pfizer Inc.
Sep 20, 2018 Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx ... CGMP Deviations; rejected product was used to manufacture final bulk lot Class II Pfizer Inc.
Sep 19, 2018 Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, ... Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. Th... Class II Pfizer Inc.
Sep 19, 2018 Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: U... Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified... Class II Upsher Smith Laboratories, Inc.
Sep 19, 2018 Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: U... Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified... Class II Upsher Smith Laboratories, Inc.
Sep 17, 2018 SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g t... Microbial Contamination of Non-Sterile Product Class II Medline Industries Inc
Sep 11, 2018 Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ... Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th... Class II Torrent Pharma Inc.
Sep 10, 2018 Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL I... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- ND... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, H... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 1... Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes o... Class II Takeda Development Center Americas, Inc.
Sep 10, 2018 Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 6... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Pow... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC

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.