Hazard Type

Product Quality Recalls

2,865 product recalls involving product quality. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

2,865Total Recalls
260Critical
322.2MUnits Affected
All Recalls

Every Product Quality Recall

Sorted by most recent. Click any recall for full details and safety information.

2,865 recalls
High RiskFDA
Sanofi-aventis U.s. Llc
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Injectable Drugs·19,580 affected·Apr 27, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA...
Topical Drugs·23,453 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufac...
Topical Drugs·17,939 affected·Apr 13, 2018
RecallFDA
Septodont Inc.
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed b...
Injectable Drugs·8,509 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA...
Topical Drugs·12,572 affected·Apr 13, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manuf...
Topical Drugs·9,016 affected·Apr 9, 2018
RecallFDA
Leadiant Biosciences, Inc
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 f...
Ophthalmic Drugs·3,398 affected·Apr 9, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Coastal Meds, Llc.
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·3,959 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·1,457 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·8,099 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·635 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·200 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·3,733 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·4,524 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·1,309 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·1,506 affected·Apr 5, 2018
High RiskFDA
Coastal Meds, Llc.
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Injectable Drugs·745 affected·Apr 5, 2018
RecallFDA
Akorn, Inc.
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0...
Oral Drugs·48,176 affected·Mar 29, 2018
RecallFDA
Akorn, Inc.
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0...
Oral Drugs·20,587 affected·Mar 29, 2018
Medium RiskFDA
Akorn, Inc.
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (ND...
Oral Drugs·561,800 affected·Mar 29, 2018
High RiskFDA
Lupin Pharmaceuticals Inc.
Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), ...
Oral Drugs·40,824 affected·Mar 27, 2018
RecallFDA
Mayne Pharma Inc
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Drugs·3,312 affected·Mar 21, 2018
Medium RiskFDA
Alva-amco Pharmacal Companies., Inc.
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharm...
Topical Drugs·206,513 affected·Mar 9, 2018
RecallFDA
Akorn, Inc.
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured b...
Drugs·4,128 affected·Mar 9, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to ...
Respiratory Devices·2 affected·Mar 9, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to...
Respiratory Devices·16 affected·Mar 9, 2018
Medium RiskFDA
Novel Laboratories, Inc.
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, ...
Oral Drugs·134,364 affected·Mar 5, 2018
High RiskFDA
Sagent Pharmaceuticals Inc
methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Sch...
Injectable Drugs·205,370 affected·Mar 5, 2018
RecallFDA
Invagen Pharmaceuticals, Inc.
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 ...
Injectable Drugs·3,222 affected·Mar 5, 2018
High RiskFDA
Sagent Pharmaceuticals Inc
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Sc...
Injectable Drugs·48,964 affected·Mar 5, 2018
High RiskFDA
Sagent Pharmaceuticals Inc
methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Sc...
Injectable Drugs·176,410 affected·Mar 5, 2018
RecallFDA
Renaissance Lakewood, Llc
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifescien...
Injectable Drugs·1,277 affected·Mar 2, 2018
RecallFDA
Osmotica Pharmaceutical Corp
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 0...
Oral Drugs·19,664 affected·Feb 28, 2018
RecallFDA
Astrazeneca Pharmaceuticals Lp
Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 ...
Oral Drugs·18,056 affected·Feb 23, 2018
High RiskFDA
B. Braun Medical Inc
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catal...
Drugs·17,360 affected·Feb 16, 2018
High RiskFDA
Medline Industries Inc
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industri...
Drugs·67,104 affected·Feb 15, 2018