Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Nov 19, 2015	NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industri...	Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.	Class III	Teva Pharmaceuticals USA
Nov 11, 2015	Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma In...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Instituti...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, R...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Ba...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutiona...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, ...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Ind...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 10, 2015	Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti...	Labeling: Not elsewhere classified. NDC number is incorrect on the container.	Class III	Northwind Pharmaceuticals LLC
Oct 27, 2015	Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ...	Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of...	Class II	Steris Corp
Oct 20, 2015	Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott...	Labeling: Incorrect or Missing Lot AND/OR Exp Date.	Class III	Teva Pharmaceutical Industries
Oct 19, 2015	HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ...	Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp...	Class III	Oasis Medical, Inc.
Oct 19, 2015	HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001...	Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp...	Class III	Oasis Medical, Inc.
Oct 13, 2015	Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine H...	Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as a...	Class III	Rx PAK
Oct 1, 2015	Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric a...	Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the...	Class III	Tribute Pharmaceuticals US Inc.
Oct 1, 2015	Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen...	Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the...	Class III	Tribute Pharmaceuticals US Inc.
Sep 29, 2015	Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 o...	Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be t...	Class I	Fit Firm and Fabulous
Sep 25, 2015	ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottl...	Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla...	Class I	Medline Industries Inc
Sep 25, 2015	ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle,...	Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla...	Class I	Medline Industries Inc
Sep 17, 2015	WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External An...	Labeling: Incorrect Instructions; The word not is missing from the following sentences "do band...	Class II	The Mentholatum Co.
Aug 24, 2015	Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distribu...	Labeling: Wrong Bar Code	Class II	C. O. Truxton
Aug 24, 2015	Xcellerator (product not labeled)	Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ...	Class I	Novacare, LLC
Aug 24, 2015	TruTrim (product not labeled)	Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ...	Class I	Novacare, LLC
Aug 21, 2015	Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone ...	Defective Container: Product missing safety seal around the neck of the bottle. The product labe...	Class III	Akorn, Inc.
Aug 21, 2015	Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx o...	Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the...	Class III	Silarx Pharmaceutical, Inc.
Aug 13, 2015	AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured fo...	Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.	Class III	Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Jul 16, 2015	Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg ...	Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml inst...	Class II	Safecor Health, LLC
Jul 16, 2015	Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jun 30, 2015	KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi...	Crystallization; identified as calcium salt of Ketorolac	Class II	Hospira Inc.
Jun 30, 2015	KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via...	Crystallization; identified as calcium salt of Ketorolac	Class II	Hospira Inc.
Jun 10, 2015	NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count b...	Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an ...	Class II	AstraZeneca Pharmaceuticals LP
Jun 4, 2015	Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ...	Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro...	Class III	Actavis Inc
May 21, 2015	SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: In...	Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey ...	Class II	Medtech Products, Inc.
May 15, 2015	MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37...	Labeling: incorrect or missing lot number and/or expiration date	Class II	Mallinckrodt, Inc.
May 12, 2015	Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and l...	CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer c...	Class II	Allegiant Health
Apr 28, 2015	PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0...	Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chlo...	Class II	SCA Pharmaceuticals
Apr 28, 2015	KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electro...	Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids	Class II	Fresenius Kabi USA, LLC
Apr 15, 2015	Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pai...	Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ...	Class I	Reckitt Benckiser LLC
Apr 15, 2015	Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain ...	Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ...	Class I	Reckitt Benckiser LLC
Apr 15, 2015	Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/...	Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ...	Class I	Reckitt Benckiser LLC
Apr 15, 2015	Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorpha...	Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ...	Class I	Reckitt Benckiser LLC
Apr 15, 2015	Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Ma...	Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ...	Class I	Reckitt Benckiser LLC
Apr 15, 2015	Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two...	Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ...	Class I	Reckitt Benckiser LLC
Apr 15, 2015	Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppres...	Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ...	Class II	Reckitt Benckiser LLC
Apr 14, 2015	Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis...	Subpotent Drug: Flurandrenolide is subpotent.	Class III	Actavis Laboratories

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.