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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2017 | Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX O... | Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalpro... | Class II | Unichem Pharmaceuticals Usa Inc |
| Dec 18, 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count ... | Subpotent Drug | Class III | Osmotica Pharmaceutical Corp |
| Dec 18, 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count ... | Subpotent Drug | Class III | Osmotica Pharmaceutical Corp |
| Dec 15, 2017 | Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distribut... | Presence of particulate matter | Class II | Amneal Pharmaceuticals |
| Dec 15, 2017 | Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bo... | CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufact... | Class III | Akorn Inc |
| Dec 15, 2017 | 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), ... | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material... | Class II | B. Braun Medical Inc |
| Dec 14, 2017 | Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate... | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | Class II | SHISEIDO AMERICA INC. |
| Dec 14, 2017 | Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (... | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | Class II | SHISEIDO AMERICA INC. |
| Dec 14, 2017 | bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titan... | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | Class II | SHISEIDO AMERICA INC. |
| Dec 14, 2017 | Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg,... | Failed Impurities/Degradation Specifications: High out of specification test result for the Moexi... | Class II | Teva Pharmaceuticals USA |
| Dec 14, 2017 | SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90... | Failed Stability Specifications | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Dec 14, 2017 | Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, ... | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | Class II | SHISEIDO AMERICA INC. |
| Dec 14, 2017 | Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octoc... | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | Class II | SHISEIDO AMERICA INC. |
| Dec 13, 2017 | INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx ... | Failed Stability Specifications: Product stability testing results did not meet specifications fo... | Class II | ALLERGAN |
| Dec 12, 2017 | Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 ... | Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burk... | Class II | Woodfield Pharmaceutical, LLC |
| Dec 12, 2017 | Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufa... | Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing ... | Class III | Keryx Biopharmaceuticals, Inc. |
| Dec 7, 2017 | Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifyin... | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from th... | Class II | Johnson & Johnson |
| Dec 7, 2017 | Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosoli... | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from th... | Class II | Johnson & Johnson |
| Dec 7, 2017 | Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syring... | Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and bey... | Class II | SCA Pharmaceuticals |
| Dec 7, 2017 | Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%),... | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from th... | Class II | Johnson & Johnson |
| Dec 7, 2017 | BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-cou... | Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibut... | Class I | BotanicalNow |
| Dec 5, 2017 | Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count ... | Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found p... | Class III | Sanofi-Aventis U.S. LLC |
| Dec 4, 2017 | Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, ... | Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did ... | Class II | ALLERGAN |
| Dec 4, 2017 | Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only,... | Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) ... | Class I | AuroMedics Pharma LLC |
| Dec 4, 2017 | Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/... | Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg | Class II | Solco Healtcare US LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Sufentani... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Fentanyl ... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Morphine ... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 30, 2017 | All sterile drug preparations remaining within expiry prepared from Hydromorp... | Lack of sterility assurance. | Class II | Intrathecal Compounding Specialist, LLC |
| Nov 30, 2017 | Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Te... | Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil | Class III | BYL Solutions Inc. |
| Nov 29, 2017 | BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long B... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sil... | Class I | Blue Fusion Natural |
| Nov 29, 2017 | Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Z... | Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets... | Class II | Prinston Pharmaceutical Inc |
| Nov 28, 2017 | Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titani... | CGMP Deviations: products manufactured in a manner that may impact product quality that includes ... | Class II | EAI-JR286 INC |
| Nov 28, 2017 | Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 1... | Failed Impurities/Degradation Specifications: high out of specification test results obtained for... | Class III | Teva Pharmaceuticals USA |
| Nov 21, 2017 | Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Ma... | Failed Dissolution Specification | Class III | Lupin Pharmaceuticals Inc. |
| Nov 20, 2017 | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... | Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... | Class II | Teva Pharmaceuticals USA |
| Nov 20, 2017 | Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count... | Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets | Class II | Zydus Pharmaceuticals USA Inc |
| Nov 20, 2017 | Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: G... | CGMP Deviations: Market complaints related to "gritty texture". | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 19, 2017 | Hard Times For Men capsules, packaged in a 23-count box of blister packs cont... | Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredie... | Class I | www.blankterrmall.com |
| Nov 17, 2017 | Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufacture... | Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy compla... | Class II | Lupin Limited |
| Nov 16, 2017 | Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Bi... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechno... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Globa... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commer... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx On... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, R... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global B... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mes... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, 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.