Browse Drug Recalls

2,101 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,101 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 2,101 FDA drug recalls in NJ.

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DateProductReasonClassFirm
Mar 27, 2018 Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 19, 2018 Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... Class III Glenmark Pharmaceuticals Inc., USA
Mar 15, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare Pharmaceuticals, Inc.
Mar 8, 2018 E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Ma... Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - met... Class II Bracco Diagnostics Inc.
Mar 8, 2018 Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... Class III Dr. Reddy's Laboratories, Inc.
Mar 5, 2018 Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... Failed Impurities/Degradation Specifications Class III Novel Laboratories, Inc.
Mar 5, 2018 Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johns... Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morph... Class II Johnson Matthey Inc.
Mar 2, 2018 Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flex... Superpotent and Failed Stability Specifications; out of specification results for assay and water... Class III Renaissance Lakewood, LLC
Feb 23, 2018 Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%... Labeling: Label mix-up Class II Bayer HealthCare Pharmaceuticals, Inc.
Feb 21, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmoti... Class II Renaissance Lakewood, LLC
Feb 5, 2018 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... Class III Sun Pharmaceutical Industries, Inc.
Feb 2, 2018 NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... Class III ALLERGAN
Feb 2, 2018 Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, M... Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg Class III Aurobindo Pharma Ltd.
Jan 29, 2018 Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Re... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 19, 2018 Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured i... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg g... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Reiki Glutathione Whitening kits Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... Discoloration: Product is supposed to be a white to off white homogenous cream and may have inter... Class III G & W Laboratories, Inc.
Jan 19, 2018 Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg v... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettab... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Relumins Vitamin C Solvent ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 TP Drug Laboratories Vitamin C ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Ling Zhi capsules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 16, 2018 DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Si... Lack Of Assurance Of Sterility Class II Sun Pharmaceutical Industries, Inc.
Jan 12, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U... Presence of Particulate Matter; contains visible particulate matter identified as mold. Class I AuroMedics Pharma LLC
Dec 20, 2017 Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use ... Presence of Particulate Matter; white particulate matter identified as mold was found in one bag Class I AuroMedics Pharma LLC
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 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 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 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 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 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

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.