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
Feb 17, 2017	Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Servic...	Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.	Class III	Pharmedium Services, LLC
Feb 15, 2017	Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Pharmedium Services Llc
Feb 15, 2017	Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Pharmedium Services Llc
Feb 15, 2017	Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Pharmedium Services Llc
Feb 15, 2017	Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Pharmedium Services Llc
Feb 15, 2017	Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Pharmedium Services Llc
Feb 15, 2017	Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Pharmedium Services Llc
Feb 15, 2017	Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium ...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Pharmedium Services Llc
Feb 13, 2017	PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TO...	Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.	Class III	Colgate Palmolive Co
Feb 2, 2017	Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (N...	Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stat...	Class II	Sandoz Inc
Feb 2, 2017	Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Cover...	Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Ca...	Class III	Sage Products Inc
Jan 27, 2017	Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 ...	Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of...	Class III	Pharmedium Services, LLC
Jan 19, 2017	Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) ...	Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized...	Class II	LEO PHARMA INC
Jan 16, 2017	Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, ...	Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-...	Class III	LEO PHARMA INC
Dec 6, 2016	INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only,...	Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed vari...	Class III	Cipher Pharmaceuticals US LLC
Dec 2, 2016	Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, R...	Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 25...	Class III	Shire PLC
Nov 22, 2016	Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed...	Labeling: Label Mix Up- Incorrect back label applied to the product.	Class III	Les Emballages Knowlton Inc.
Nov 8, 2016	Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3....	Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and ...	Class III	Care-Tech Laboratories, Inc.
Nov 4, 2016	Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted)...	Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the stren...	Class III	West-Ward Pharmaceuticals Corp.
Oct 21, 2016	Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akor...	Subpotent Drug: concentration of product is less than labeled amount.	Class II	Akorn Inc
Oct 20, 2016	FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx on...	Labeling: Label error on declared strength. Package Insert -Error in the Description section of t...	Class III	CutisPharma, Inc.
Oct 20, 2016	FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx ...	Labeling: Label error on declared strength. Package Insert -Error in the Description section of t...	Class III	CutisPharma, Inc.
Oct 19, 2016	Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM ...	Labeling: Missing Label	Class III	Sandoz Inc
Oct 19, 2016	Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-coun...	Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be a...	Class III	Janssen Ortho L.L.C.
Oct 18, 2016	Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 O...	Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of...	Class III	GSK Consumer Healthcare
Oct 12, 2016	HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection...	Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units inste...	Class III	Pharm D Solutions, LLC
Sep 16, 2016	Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50...	Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo...	Class II	Hospira Inc., A Pfizer Company
Sep 16, 2016	Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL...	Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo...	Class II	Hospira Inc., A Pfizer Company
Sep 15, 2016	Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carto...	Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no prod...	Class III	Mckesson Packaging Services
Sep 15, 2016	PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx o...	Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expi...	Class III	Pfizer Inc.
Sep 8, 2016	Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart...	Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but...	Class III	Mckesson Packaging Services
Sep 1, 2016	Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ...	Labeling: Incorrect or Missing Package Insert	Class III	Sanofi-Aventis U.S. LLC
Aug 30, 2016	Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A...	Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration...	Class III	Actavis Laboratories, FL, Inc.
Aug 19, 2016	Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blister...	Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg bl...	Class I	Impax Laboratories, Inc.
Aug 18, 2016	Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re...	Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of...	Class III	West-Ward Pharmaceuticals Corp.
Aug 4, 2016	Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For...	Labeling: Incorrect or Missing Lot and/or Exp. Date	Class III	Genzyme Corporation / Genzyme Biosurgery
Aug 3, 2016	Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippa...	Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydram...	Class III	Reckitt Benckiser LLC
Jul 29, 2016	2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p...	CGMP Deviations: potential contamination of products manufactured on the same equipment and lines...	Class II	Sage Products LLC
Jun 28, 2016	DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only,...	Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label ...	Class III	Golden State Medical Supply Inc.
Jun 13, 2016	Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur...	Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is print...	Class III	Jubilant Cadista Pharmaceuticals, Inc.
Jun 10, 2016	SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ...	Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphy...	Class III	Valeant Pharmaceuticals North America LLC
May 30, 2016	Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa...	Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ...	Class III	Prinston Pharmaceutical Inc
May 25, 2016	Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa...	Labeling: Incorrect or Missing Package Insert	Class III	Sandoz Inc
May 23, 2016	Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul...	Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were ...	Class III	Valeant Pharmaceuticals North America LLC
May 19, 2016	Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Markete...	Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.	Class III	Galderma Laboratories, L.P.
May 16, 2016	Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMED...	Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label s...	Class II	Pharmedium Services, LLC
May 10, 2016	Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (1...	Labeling; Product Contains Undeclared API (Oxybenzone)	Class II	Bayer Health Care LLC
Apr 29, 2016	BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifes...	Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.	Class I	Making It a Lifestyle
Apr 27, 2016	Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Ge...	Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL ...	Class III	Genzyme Corporation / Genzyme Biosurgery
Apr 22, 2016	Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bot...	Labeling: Not elsewhere classified - count on the label was incorrect.	Class III	A-S Medication 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.