Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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Date	Product	Reason	Class	Firm
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	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	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 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 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	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 5, 2018	Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90...	Container packaging defect.	Class III	Orexigen Therapeutics, Inc.
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 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	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 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	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 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	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	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	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 VaricoGo 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	Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360...	Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce...	Class III	Baxter Healthcare Corporation
Sep 25, 2018	Progesterone SR 100 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	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.
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	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	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 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 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 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	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 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 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 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	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 18, 2018	Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 m...	Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging com...	Class III	Xiromed LLC
Sep 17, 2018	treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for...	Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel...	Class III	Otsuka Pharmaceutical Development & Commerciali...
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 17, 2018	treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for ...	Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel...	Class III	Otsuka Pharmaceutical Development & Commerciali...
Sep 17, 2018	robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ...	Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly...	Class I	Endo Pharmaceuticals, Inc.
Sep 12, 2018	Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for:...	Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-min...	Class III	Hetero Labs, Ltd. - Unit III
Sep 12, 2018	Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd B...	Failed Impurities/Degradation Specifications: OOS for unknown impurities.	Class III	Dr. Reddy's Laboratories, Inc.
Sep 12, 2018	Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bot...	Failed Impurities/Degradation Specifications: OOS for unknown impurities.	Class III	Dr. Reddy's Laboratories, 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 ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, ...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, ...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Hou...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D So...	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.