Browse Drug Recalls

1,020 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,020 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 1,020 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Mar 14, 2016	Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 m...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/m...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, Inc
Feb 12, 2016	Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Myl...	Failed Dissolution Specifications; three month stability time point.	Class II	Mylan Pharmaceuticals Inc.
Feb 11, 2016	sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp condition...	Subpotent Drug: failed at the 3 and 6 month stability time points.	Class III	J. Strickland and Co
Feb 11, 2016	Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only...	Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceedi...	Class II	Sun Pharma Global Fze
Feb 5, 2016	Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By...	Failed Impurities/Degradation Specifications: Out of specification test results for impurities du...	Class II	Teva Pharmaceuticals USA
Jan 26, 2016	Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, M...	Failed Dissolution Specification: Out of specification dissolution results when testing product s...	Class III	Apotex Scientific, Inc
Jan 26, 2016	Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, M...	Failed Dissolution Specification: Out of specification dissolution results when testing product s...	Class III	Apotex Scientific, Inc
Jan 26, 2016	Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Di...	Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)	Class III	Amerisource Health Services
Jan 26, 2016	Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, M...	Failed Dissolution Specification: Out of specification dissolution results when testing product s...	Class III	Apotex Scientific, Inc
Dec 31, 2015	Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) ...	Failed Impurities/Degradation Specifications; 9 month stability timepoint	Class III	Sandoz Inc
Dec 17, 2015	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 f...	Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result de...	Class III	Bio-pharm, Inc.
Dec 15, 2015	Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottl...	Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.	Class III	Morton Grove Pharmaceuticals, Inc.
Nov 12, 2015	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT...	Failed Impurities/Degradation Specifications: High out of specification test result for impuritie...	Class II	Teva Pharmaceuticals USA
Oct 21, 2015	RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 m...	Failed Stability Specifications: Out of Specification results obtained for preservative butylpara...	Class III	Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Sep 29, 2015	Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL,...	Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation p...	Class III	Hospira Inc.
Aug 21, 2015	HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, R...	Stability Data Does Not Support Expiry	Class II	Cantrell Drug Company
Aug 21, 2015	HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), ...	Stability Data Does Not Support Expiry	Class II	Cantrell Drug Company
Aug 19, 2015	Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 m...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Tot...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in ...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 ...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 1...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosag...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharma...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, ...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 m...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syring...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, ...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in s...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 19, 2015	Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL i...	Stability data does not support expiry.	Class II	Pharmakon Pharmaceuticals
Aug 17, 2015	Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 cou...	Failed Stability Specifications: product may not meet specification limit for assay test.	Class II	Apotex Inc.
Jul 28, 2015	Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsule...	Failed Dissolution Specifications: Product is being recalled due to out of specification (above s...	Class III	Novartis Pharmaceuticals Corp.
Jul 21, 2015	Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC ...	Failed impurities/Degradation specifications: out of specification results for individual unknown...	Class III	PD-Rx Pharmaceuticals, Inc.
Jul 17, 2015	fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volu...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 m...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, ...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a s...	Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in ...	Class II	Pharmedium Services, LLC
Jul 17, 2015	morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Prese...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volu...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Tot...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, ...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, LLC
Jul 17, 2015	glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syring...	Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in...	Class II	Pharmedium Services, 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.