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
Imprimis Njof, Llc
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgew...
Drugs·6,880 affected·Jul 9, 2025
High RiskFDA
Boothwyn Pharmacy Llc
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Injectable Drugs·642 affected·Jul 9, 2025
High RiskFDA
Ascend Laboratories, Llc
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribute...
Oral Drugs·0 affected·Jul 9, 2025
High RiskFDA
Boothwyn Pharmacy Llc
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Injectable Drugs·648 affected·Jul 9, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc...
Oral Drugs·12,242 affected·Jun 30, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 6818...
Oral Drugs·2,724 affected·Jun 27, 2025
RecallFDA
Avkare
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Oral Drugs·1,560 affected·Jun 26, 2025
RecallFDA
Avkare
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Oral Drugs·8,573 affected·Jun 26, 2025
Medium RiskFDA
Gmp Laboratories Of America Inc
Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, LLC. San Francisc...
Supplements·185,482 affected·Jun 24, 2025
Medium RiskFDA
Gmp Laboratories Of America Inc
Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, San Fransisco, CA ...
Supplements·185,482 affected·Jun 24, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC ...
Oral Drugs·4,921 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27...
Oral Drugs·82,159 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 276...
Oral Drugs·54,227 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC...
Oral Drugs·2,344 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC...
Oral Drugs·4,896 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC ...
Oral Drugs·2,352 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2...
Oral Drugs·9,739 affected·Jun 20, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901,...
Oral Drugs·5,448 affected·Jun 16, 2025
RecallFDA
Orient Pharma Co., Ltd. Yunlin Plant
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 6...
Oral Drugs·20,618 affected·Jun 11, 2025
RecallFDA
Orient Pharma Co., Ltd. Yunlin Plant
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 6...
Oral Drugs·57,504 affected·Jun 11, 2025
High RiskFDA
Recordati Rare Diseases Inc.
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solut...
Medical Devices·3,754 affected·Jun 11, 2025
High RiskFDA
Immunocore, Llc
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limi...
Injectable Drugs·7,572 affected·Jun 10, 2025
High RiskFDA
Eugia Us Llc
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, ...
Injectable Drugs·48,000 affected·May 29, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs·10,620 affected·May 23, 2025
High RiskFDA
Consumer Product Partners, Llc
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three La...
Topical Drugs·125,040 affected·May 23, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs·48,936 affected·May 23, 2025
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase...
Oral Drugs·6,759 affected·May 19, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·22,152 affected·May 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·30,674 affected·May 13, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administ...
Medical Devices·14,280 affected·May 12, 2025
High RiskFDA
Bso Llc
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Offi...
Drugs·2,762 affected·Apr 28, 2025
High RiskFDA
Bso Llc
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar...
Drugs·1,964 affected·Apr 28, 2025
High RiskFDA
Bso Llc
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Offi...
Drugs·1,447 affected·Apr 28, 2025
High RiskFDA
Bso Llc
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX o...
Drugs·355 affected·Apr 28, 2025
High RiskFDA
Bso Llc
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Offi...
Drugs·1,974 affected·Apr 28, 2025
CriticalFDA
Amneal Pharmaceuticals, Llc
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, I...
Injectable Drugs·62 affected·Apr 17, 2025
RecallFDA
Ourpharma Llc
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayettevill...
Drugs·1,375 affected·Apr 15, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distribute...
Oral Drugs·16,473 affected·Apr 14, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx O...
Oral Drugs·343,344 affected·Apr 14, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major...
Oral Drugs·133 affected·Apr 14, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617,...
Oral Drugs·4,885 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, ...
Oral Drugs·18,984 affected·Apr 10, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 2...
Oral Drugs·2,724 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, ...
Oral Drugs·4,872 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617,...
Oral Drugs·4,888 affected·Apr 10, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Di...
Oral Drugs·3,144 affected·Apr 3, 2025
High RiskFDA
B. Braun Medical Inc
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc.,...
Drugs·32,256 affected·Mar 31, 2025
High RiskFDA
Ultra Clean Systems, Inc.
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Medical Devices·96 affected·Mar 31, 2025