Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Nov 3, 2017 Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocai... GMP Deviations: inadequate manufacturing control processes Class II Ridge Properties, LLC
Nov 3, 2017 Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%)... GMP Deviations: inadequate manufacturing control processes Class II Ridge Properties, LLC
Nov 3, 2017 Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lido... GMP Deviations: inadequate manufacturing control processes Class II Ridge Properties, LLC
Nov 3, 2017 Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL... GMP Deviations: inadequate manufacturing control processes Class II Ridge Properties, LLC
Nov 3, 2017 Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69... GMP Deviations: inadequate manufacturing control processes Class II Ridge Properties, LLC
Oct 30, 2017 ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 ... Subpotent Drug Class II Pharmedium Services, LLC
Oct 25, 2017 Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552... cGMP Deviations: lack of quality assurance at the API manufacturer. Class II Fagron, Inc
Oct 25, 2017 Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-co... Failed dissolution specifications; all lots within expiry are being recalled due to out of specif... Class II Teva Pharmaceuticals USA
Oct 24, 2017 Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed b... Presence of Foreign Tablets/Capsules. Class II Amerisource Health Services
Oct 24, 2017 Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by... Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of... Class II Ace Surgical Supply Co., 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.
Oct 19, 2017 fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (20... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmace... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL sin... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUC... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag conta... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 13, 2017 Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packa... Superpotent drug: out of specification result for potency Class II PharMEDium Services, LLC.
Oct 12, 2017 Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) ... Presence of foreign substance (screw) Class II Hetero Labs, Ltd. - Unit III
Oct 10, 2017 Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Bann... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx O... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner ... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Ba... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Ba... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Bann... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Com... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Onl... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chlo... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Phar... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 6, 2017 A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottl... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sib... Class II Kiriko, LLC.
Oct 6, 2017 Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dos... Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. Class II AVKARE Inc.
Oct 6, 2017 No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, D... Marketed Without an Approved NDA/ANDA Class II NEW RELIANCE TRADING, INC.
Oct 5, 2017 Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue... Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer w... Class II Purdue Pharma, LP
Oct 2, 2017 Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured ... Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was o... Class II Unichem Pharmaceuticals Usa Inc
Sep 28, 2017 Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured b... Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablet... Class II Leading Pharma, LLC
Sep 27, 2017 Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), ... CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unk... Class II United Pharmacy
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 26, 2017 Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL ... Superpotent Drug Class II Pharmedium Services, LLC
Sep 26, 2017 Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. Class II The Harvard Drug Group
Sep 25, 2017 methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Co... Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves u... Class II RXQ Compounding LLC
Sep 21, 2017 Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico f... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries Inc
Sep 21, 2017 Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for... Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label c... Class II Medline Industries 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.