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
CriticalFDA
Avet Pharmaceuticals, Inc.
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 088...
Oral Drugs·17,524 affected·Mar 23, 2020
CriticalFDA
Avet Pharmaceuticals, Inc.
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 088...
Oral Drugs·4,444 affected·Mar 23, 2020
High RiskFDA
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Asso...
Oral Drugs·7,416 affected·Mar 19, 2020
High RiskFDA
Matthew 7:25 Inc Dba Thrive Pharmacy
Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff...
Topical Drugs·71 affected·Mar 10, 2020
High RiskFDA
Matthew 7:25 Inc Dba Thrive Pharmacy
Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff...
Drugs·89 affected·Mar 10, 2020
High RiskFDA
Matthew 7:25 Inc Dba Thrive Pharmacy
Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff R...
Drugs·403 affected·Mar 10, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Oral Drugs·300 affected·Mar 9, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets ...
Oral Drugs·9,897 affected·Mar 9, 2020
RecallFDA
Lupin Pharmaceuticals Inc.
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet...
Oral Drugs·1,712 affected·Mar 9, 2020
High RiskFDA
Yusef Manufacturing Laboratories, Llc
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL ...
Drugs·12,983 affected·Mar 3, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·11,093 affected·Mar 2, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·7,469 affected·Mar 2, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·9,513 affected·Mar 2, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·13,761 affected·Mar 2, 2020
RecallFDA
Akorn, Inc.
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60...
Topical Drugs·24 affected·Feb 21, 2020
RecallFDA
Akorn, Inc.
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 0289...
Topical Drugs·0 affected·Feb 21, 2020
RecallFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Topical Drugs·720 affected·Feb 21, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauder...
Oral Drugs·3,695 affected·Feb 20, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Topical Drugs·876 affected·Feb 19, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control m...
Diagnostic Devices·10 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog...
Diagnostic Devices·3 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Diagnostic Devices·183 affected·Feb 18, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltim...
Oral Drugs·6,294 affected·Feb 12, 2020
RecallFDA
Auromedics Pharma Llc
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not fo...
Injectable Drugs·4,600 affected·Feb 7, 2020
High RiskFDA
Unichem Pharmaceuticals Usa Inc
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pi...
Oral Drugs·19,161,600 affected·Jan 29, 2020
High RiskFDA
Ncs Healthcare Of Kentucky Inc
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42...
Drugs·6,929 affected·Jan 28, 2020
RecallFDA
Macleods Pharma Usa Inc
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. ...
Oral Drugs·4,694 affected·Jan 24, 2020
RecallFDA
Ascend Laboratories Llc
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mum...
Oral Drugs·4,728 affected·Jan 22, 2020
RecallFDA
Macleods Pharma Usa Inc
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufac...
Oral Drugs·10,680 affected·Jan 20, 2020
High RiskFDA
Direct Rx
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
Drugs·26 affected·Jan 15, 2020
High RiskFDA
Direct Rx
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct...
Drugs·54 affected·Jan 15, 2020
High RiskFDA
Pharmaceutical Associates Inc
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, ...
Oral Drugs·6,288 affected·Jan 14, 2020
High RiskFDA
Spectrum Laboratory Products
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 gra...
Drugs·0 affected·Jan 14, 2020
High RiskFDA
Letco Medical Llc
Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) ...
Drugs·597 affected·Jan 10, 2020
RecallFDA
Lupin Pharmaceuticals Inc.
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3...
Oral Drugs·34,080 affected·Jan 10, 2020
High RiskFDA
Avkare Inc.
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 5...
Oral Drugs·3,989 affected·Jan 7, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Oral Drugs·31,736 affected·Jan 7, 2020
High RiskFDA
Appco Pharma Llc
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharm...
Oral Drugs·1,632 affected·Jan 7, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Oral Drugs·16,944 affected·Jan 7, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 6...
Oral Drugs·39,172 affected·Jan 7, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388...
Oral Drugs·221,710 affected·Jan 7, 2020
High RiskFDA
Appco Pharma Llc
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by:...
Oral Drugs·624 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·4,563 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·101 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·297 affected·Jan 7, 2020
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Phar...
Oral Drugs·7,212 affected·Jan 6, 2020
CriticalFDA
Remedyrepack Inc.
Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
Drugs·75 affected·Dec 27, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
Oral Drugs·207,585 affected·Dec 26, 2019