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
Oct 17, 2019	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
Oct 11, 2019	Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manuf...	Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.	Class III	X-Gen Pharmaceuticals Inc.
Oct 1, 2019	Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) ...	Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.	Class III	Sato Pharmaceutical Inc.
Sep 27, 2019	Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose,...	Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1...	Class III	Arbor Pharmaceuticals Inc.
Sep 26, 2019	Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial....	Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed ...	Class II	Alkermes, Inc.
Sep 13, 2019	Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, pac...	Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring...	Class II	GUERBET LLC
Sep 13, 2019	Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefille...	Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring...	Class III	GUERBET LLC
Sep 12, 2019	ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by...	Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco...	Class III	Pfizer Inc.
Sep 12, 2019	Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made...	Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco...	Class III	Pfizer Inc.
Sep 6, 2019	Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For...	Temperature Abuse; Product stored and shipped outside of labeled storage requirements.	Class II	Cardinal Health dba Specialty Pharmaceutical Se...
Sep 6, 2019	Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N...	Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a...	Class I	Darmerica, LLC
Aug 28, 2019	Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Sou...	Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product i...	Class II	Atlas Pharmaceuticals, LLC
Aug 27, 2019	Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N...	Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths secti...	Class III	American Health Packaging
Aug 8, 2019	Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial....	Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed...	Class II	Alkermes Inc
Jul 29, 2019	Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: A...	Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054...	Class III	Aurobindo Pharma USA Inc.
Jul 15, 2019	LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, ...	Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling o...	Class II	La Fresh Group, Inc.
Jul 11, 2019	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste...	Labeling: Missing label; Product complaints reported missing bottle label.	Class III	Lupin Pharmaceuticals Inc.
Jun 25, 2019	Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U...	Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da...	Class III	AAA Pharmaceutical, Inc.
Jun 7, 2019	Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu...	Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar...	Class III	Akorn Inc
May 28, 2019	Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredient...	Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage informat...	Class I	Novis PR, Inc.
May 13, 2019	Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactur...	Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo...	Class II	MALLINCKRODT PHARMACEUTICALS
May 13, 2019	Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufacture...	Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were fo...	Class II	MALLINCKRODT PHARMACEUTICALS
May 2, 2019	Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 c...	Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printe...	Class II	Septodont Inc.
Apr 29, 2019	Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ...	Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax...	Class III	Pfizer Inc.
Apr 25, 2019	Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by:...	Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act...	Class II	Zydus Pharmaceuticals USA Inc
Apr 25, 2019	Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2...	Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the n...	Class III	Advantice Health
Apr 25, 2019	Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2...	Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rathe...	Class III	Advantice Health
Apr 25, 2019	Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: C...	Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act...	Class II	Zydus Pharmaceuticals USA Inc
Apr 22, 2019	ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE San...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) ...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soa...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 19, 2019	FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx...	Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 ...	Class I	Alvogen, Inc
Mar 29, 2019	Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, ...	Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration...	Class III	X-Gen Pharmaceuticals Inc.
Mar 25, 2019	Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By....	Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.	Class II	Lohxa LLC
Mar 25, 2019	Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. ...	Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.	Class II	Lohxa LLC
Mar 22, 2019	Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building...	Failed pH Specification: product does not meet pH label claim.	Class III	Auro Pharmacies Inc. DBA Central Drugs
Mar 19, 2019	Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chlor...	Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon...	Class II	LUPIN SOMERSET
Mar 7, 2019	Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the foll...	Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items con...	Class II	Medtech Products, Inc.
Mar 6, 2019	Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-0...	CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.	Class II	Preferred Pharmaceuticals, Inc
Mar 5, 2019	LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containi...	Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approve...	Class I	USA LESS Inc.
Feb 8, 2019	MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use ...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Feb 8, 2019	MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use b...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Feb 8, 2019	Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL sin...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Feb 8, 2019	MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Com...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Feb 7, 2019	Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Labo...	Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.	Class III	ACP Nimble Buyer, Inc.
Feb 6, 2019	Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of...	Labeling: Incorrect expiration date.	Class II	Advanced Pharma Inc.
Feb 6, 2019	Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj...	Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ...	Class III	Advanced Pharma Inc.
Feb 6, 2019	Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje...	Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ...	Class III	Advanced Pharma Inc.
Feb 6, 2019	Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj...	Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ...	Class III	Advanced Pharma 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.