Product category · Updated Mar 18, 2026
Drugs & Medications recalls
Prescription and over-the-counter medication recalls
Category snapshot
Drugs & Medications accounts for 13,831 recalls — about 16.5% of the 83,949-record federal archive, with 1,263 graded high-severity, most issued by FDA Drug.
- 13,831
- total recalls
- 9%
- graded high-severity
- FDA Drug
- top issuing agency
- 2000–2026
- years covered
Drugs & Medications recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 1,263
High severity
1,263 recalls
- Moderate
Moderate
10,985 recalls
- Lower severity 1,583
Lower severity
1,583 recalls
Recalls by issuing agency
- FDA Drug
FDA Drug
12,824 recalls
- FDA Food 900
FDA Food
900 recalls
- CPSC 107
CPSC
107 recalls
Recalls in Drugs & Medications
Newest first · Page 9 of 277
FDA Drug Moderate Sep 3, 2025
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, S…
MEDLINE INDUSTRIES, LP - Northfield
FDA Drug Moderate Aug 27, 2025
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. C…
PFIZER INC
FDA Drug Moderate Aug 27, 2025
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Ca…
PFIZER INC
FDA Drug Moderate Aug 27, 2025
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad,…
VIONA PHARMACEUTICALS INC
FDA Drug Moderate Aug 27, 2025
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, …
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
FDA Food Low Aug 20, 2025
Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, San Fransisco, CA 94108 2.5 m…
GMP Laboratories of America Inc
FDA Drug Moderate Aug 20, 2025
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bet…
B BRAUN MEDICAL INC
FDA Drug Moderate Aug 20, 2025
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manuf…
Glenmark Pharmaceuticals Inc., USA
FDA Drug Moderate Aug 20, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, …
Breckenridge Pharmaceutical, Inc.
FDA Drug Moderate Aug 20, 2025
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ…
Glenmark Pharmaceuticals Inc., USA
FDA Drug Moderate Aug 20, 2025
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethle…
B BRAUN MEDICAL INC
FDA Drug Moderate Aug 20, 2025
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone S…
Glenmark Pharmaceuticals Inc., USA
FDA Drug Moderate Aug 20, 2025
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: …
Ascend Laboratories, LLC
FDA Drug Moderate Aug 20, 2025
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 40351…
Glenmark Pharmaceuticals Inc., USA
FDA Drug Moderate Aug 20, 2025
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by…
Glenmark Pharmaceuticals Inc., USA
FDA Drug Moderate Aug 20, 2025
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC…
Pfizer
FDA Drug Moderate Aug 20, 2025
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrap…
Westminster Pharmaceuticals LLC
FDA Drug Moderate Aug 20, 2025
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapu…
Westminster Pharmaceuticals LLC
FDA Drug Moderate Aug 20, 2025
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufac…
Glenmark Pharmaceuticals Inc., USA
FDA Drug Moderate Aug 20, 2025
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LL…
Merck & Co. Inc
FDA Drug Moderate Aug 13, 2025
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spa…
Breckenridge Pharmaceutical, Inc.
FDA Drug Moderate Aug 13, 2025
Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL M…
AEQUITA PHARMACY
FDA Drug Moderate Aug 13, 2025
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,…
Direct Rx
FDA Drug Moderate Aug 13, 2025
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: …
SUN PHARMACEUTICAL INDUSTRIES INC
FDA Drug Moderate Aug 13, 2025
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Cardinal Health Inc.
FDA Drug Moderate Aug 13, 2025
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India,…
Alembic Pharmaceuticals Limited
FDA Drug Moderate Aug 13, 2025
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Cardinal Health Inc.
FDA Drug Moderate Aug 13, 2025
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Cardinal Health Inc.
FDA Drug Moderate Aug 13, 2025
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle,…
Direct Rx
FDA Drug Moderate Aug 6, 2025
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 341…
Lupin Pharmaceuticals Inc.
FDA Drug Moderate Aug 6, 2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Di…
FDC Limited
FDA Drug Moderate Aug 6, 2025
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactur…
Nostrum Laboratories, Inc.
FDA Drug Moderate Aug 6, 2025
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Hikma Pharmaceuticals USA Inc.
FDA Drug Moderate Aug 6, 2025
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma I…
Strides Pharma, Inc.
FDA Drug Low Jul 30, 2025
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF,…
Imprimis NJOF, LLC
FDA Drug Moderate Jul 30, 2025
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC …
Mckesson Medical-Surgical Inc. Corporate Office
FDA Drug Moderate Jul 30, 2025
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 Ledgewood, NJ, 078…
Imprimis NJOF, LLC
FDA Drug Moderate Jul 30, 2025
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Lupin Pharmaceuticals Inc.
FDA Drug Moderate Jul 30, 2025
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Mckesson Medical-Surgical Inc. Corporate Office
FDA Drug Moderate Jul 30, 2025
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Mckesson Medical-Surgical Inc. Corporate Office
FDA Drug Moderate Jul 23, 2025
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Ma…
Lupin Pharmaceuticals Inc.
FDA Drug Moderate Jul 23, 2025
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manuf…
ACCORD HEALTHCARE, INC.
FDA Drug Moderate Jul 23, 2025
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascen…
Ascend Laboratories, LLC
FDA Drug Moderate Jul 23, 2025
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufac…
ACCORD HEALTHCARE, INC.
FDA Drug Low Jul 23, 2025
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
Qualgen, LLC
FDA Drug Moderate Jul 23, 2025
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 I…
Dr. Reddy's Laboratories, Inc.
FDA Drug Moderate Jul 23, 2025
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed…
SUN PHARMACEUTICAL INDUSTRIES INC
FDA Drug Moderate Jul 23, 2025
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufact…
ACCORD HEALTHCARE, INC.
FDA Drug Moderate Jul 23, 2025
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manu…
ACCORD HEALTHCARE, INC.
FDA Drug Moderate Jul 23, 2025
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manu…
ACCORD HEALTHCARE, INC.
What to do with this
Monitoring drugs & medications? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most drugs & medications recalls come from FDA Drug — browse that agency's full feed. FDA Drug recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA — openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls
- Source: NHTSA — National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Mar 18, 2026.
Read our methodology — how this data is sourced, computed, and verified.
