Browse Drug Recalls

193 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 193 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 193 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Feb 20, 2018	Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multid...	Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and ...	Class II	Hospira Inc. A Pfizer Company
Feb 7, 2018	Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin...	Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o...	Class I	Pfizer Inc.
Feb 7, 2018	Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin...	Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o...	Class I	Pfizer Inc.
Oct 20, 2017	diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 m...	SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent	Class I	Pfizer Inc.
Oct 20, 2017	Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed ...	SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent	Class II	Pfizer Inc.
Sep 27, 2017	FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bu...	Microbial Contamination of Non-Sterile Products	Class II	Pfizer Manufacturing Deutschland GmbH
Sep 1, 2017	Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu...	Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.	Class II	Pfizer Inc.
Aug 30, 2017	Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only...	Presence of Particulate Matter: glass particulate found in vial	Class I	Pfizer Inc.
Aug 22, 2017	Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL ...	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used...	Class II	Pfizer Inc.
Aug 22, 2017	HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in c...	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used...	Class II	Pfizer Inc.
Aug 4, 2017	Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ...	Failed Dissolution Specifications	Class III	Pfizer Inc.
Aug 4, 2017	Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m...	Failed Dissolution Specifications	Class III	Pfizer Inc.
Jul 12, 2017	Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL...	CGMP Deviations: Firm failed to control impurity for color change at the API stage.	Class III	Pfizer Inc.
Jul 6, 2017	Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Onl...	Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-re...	Class III	Hospira Inc., A Pfizer Company
Jun 15, 2017	Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-d...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 15, 2017	Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 15, 2017	Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 15, 2017	8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 gr...	Lack of Sterility Assurance	Class II	Hospira a Pfizer Company
Jun 5, 2017	EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ...	Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli...	Class I	Bristol-myers Squibb Company
May 18, 2017	Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx o...	GMP Deviation; A foreign stopper was observed during packaging of a lot of product.	Class II	Hospira Inc., A Pfizer Company
Mar 12, 2017	EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured ...	Defective Delivery System; reports of the device failing to activate which could result in a pati...	Class I	Meridian Medical Technologies a Pfizer Company
Mar 12, 2017	EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for M...	Defective Delivery System; reports of the device failing to activate which could result in a pati...	Class I	Meridian Medical Technologies a Pfizer Company
Mar 7, 2017	Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900...	Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ...	Class III	Pfizer Inc
Mar 7, 2017	Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300...	Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ...	Class III	Pfizer Inc
Mar 7, 2017	Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750...	Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ...	Class III	Pfizer Inc
Feb 10, 2017	METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible ...	Lack of Sterility Assurance: customer report of leaking bag	Class II	Hospira Inc., A Pfizer Company
Jan 24, 2017	Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package ...	Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. Th...	Class I	Hospira Inc., A Pfizer Company
Nov 22, 2016	PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop...	Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.	Class III	Pfizer Inc.
Nov 7, 2016	LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, R...	Superpotent	Class II	Pfizer Inc.
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 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 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 9, 2016	Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For...	Failed Impurities/Degradations Specifications; Out of specification results for two known degrada...	Class III	Pfizer Inc.
Aug 4, 2016	Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Sing...	Presence of particulate matter: Confirmed customer report for the presence of particulate matter ...	Class I	Hospira Inc., A Pfizer Company
Apr 28, 2016	Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distribu...	Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.	Class II	Pfizer Inc.
Feb 10, 2016	Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (2...	Labeling: Label Mix-Up	Class III	Pfizer Inc
Jan 11, 2016	Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by...	FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ...	Class II	Pfizer Inc.
Jan 11, 2016	Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by...	FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ...	Class II	Pfizer Inc.
Dec 2, 2015	Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac...	Failed Dissolution Specification	Class III	Pfizer Inc.
Sep 24, 2015	Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed b...	Subpotent Drug	Class II	Pfizer Inc.
May 28, 2015	Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. ...	Lack of Assurance of Sterility: Sterility of product is not assure	Class II	Lincare, Inc.
Apr 23, 2015	Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-...	Presence of Particulate Matter	Class I	Mylan Institutional LLC
Mar 23, 2015	Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-...	Presence of Particulate Matter	Class I	Mylan Institutional LLC
Mar 18, 2015	Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac...	Presence of Particulate Matter	Class I	Mylan Institutional LLC
Feb 26, 2015	Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manuf...	Failed Impurities/Degradation Specifications	Class III	Pfizer Inc.
Feb 26, 2015	Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufac...	Failed Impurities/Degradation Specifications	Class III	Pfizer Inc.
Dec 3, 2014	Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61...	Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cra...	Class II	Pfizer Inc.
Oct 10, 2014	TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL an...	Crystallization: Impurities in a raw material used to manufacture the diluent can cause the forma...	Class III	Pfizer Inc.
Jul 30, 2014	Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL...	Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval a...	Class III	Pfizer Inc.
Jul 8, 2014	VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only...	Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex...	Class III	Pfizer 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.