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Browse Drug Recalls

1,141 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,141 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 1,141 FDA drug recalls in 2017.

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DateProductReasonClassFirm
Nov 3, 2017 bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, R... Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntar... Class III Mylan Pharmaceuticals Inc.
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
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 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 Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%)... GMP Deviations: inadequate manufacturing control processes Class II Ridge Properties, LLC
Oct 30, 2017 Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only,... Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. Class III Jubilant Cadista Pharmaceuticals, Inc.
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 30, 2017 Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, me... Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt... Class III Dr. Reddy's Laboratories, Inc.
Oct 27, 2017 Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Cont... Class I Fresenius Kabi USA, LLC
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 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 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 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 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.
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 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 Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, All... Failed Impurities/Degradation Specifications. Class III Allergan Sales, 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 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 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 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 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 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 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 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... Failed Impurities/Degradation Specifications. Class III Allergan Sales, LLC
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 17, 2017 Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: Low out of specification results for dissolution. Class III Teva Pharmaceuticals USA
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 13, 2017 Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: T... Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the i... Class III Sanofi-Aventis U.S. LLC
Oct 12, 2017 Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, R... Labeling: Incorrect or Missing Package Insert. Class III Genzyme Corporation
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 Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Phar... 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

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.