PlainRecalls

Product category · Updated Jun 3, 2026

Drugs & Medications recalls

Prescription and over-the-counter medication recalls

Total recalls
14,290
Top agency
FDA Drug
Years covered
2000–2026
Check a product → All categories

Drugs & Medications accounts for 14,290 recalls, about 14.1% of the federal recall archive, of which 10% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 14,290 drugs & medications recalls between 2000 and 2026 - roughly 14.1% of the 101,704-record archive. Of the 14,290 records graded for severity, 10% are high-severity. Most are issued by FDA Drug. Counts reflect market size and reporting activity, not a product's inherent danger.

  • 14,290 total recalls
  • 14.1% of the archive
  • 10% graded high-severity
  • FDA Drug top agency

Category snapshot

Drugs & Medications accounts for 14,290 recalls, about 14.1% of the 101,704-record federal archive, with 1,496 graded high-severity, most issued by FDA Drug.

14,290
total recalls
10%
graded high-severity
FDA Drug
top issuing agency
2000–2026
years covered

Drugs & Medications recalls by year

2000–2026

0 300 600 900 1200 1500 1800 2100 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 1843 887 925 1233 1617 638 859 1103 985 516 563 263

Source: FDA · CPSC · NHTSA As of Jun 3, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Recalls in Drugs & Medications

Newest first · Page 28 of 286

FDA Drug Moderate Dec 20, 2023

Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufacture…

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Low Dec 13, 2023

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, …

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Dec 13, 2023

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Wells Pharma of Houston LLC

FDA Drug Moderate Dec 13, 2023

KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: Kind…

KINDER FARMS LLC

FDA Drug Moderate Dec 13, 2023

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50,…

STAQ Pharma, Inc.

FDA Drug Moderate Dec 13, 2023

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. M…

Baxter Healthcare Corporation

FDA Drug Critical Dec 13, 2023

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, Fra…

Novartis Pharmaceuticals Corporation

FDA Drug Moderate Dec 13, 2023

KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: Kinder…

KINDER FARMS LLC

FDA Drug Low Dec 6, 2023

Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Us…

Fagron Compounding Services

FDA Drug Low Dec 6, 2023

Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA…

Teva Pharmaceuticals USA, Inc

FDA Drug Critical Dec 6, 2023

Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan…

Botanical Be

FDA Drug Low Dec 6, 2023

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL…

VistaPharm LLC

FDA Drug Critical Dec 6, 2023

VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. …

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Critical Dec 6, 2023

Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736…

Botanical Be

FDA Drug Critical Nov 29, 2023

ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Ma…

Exela Pharma Sciences LLC

FDA Drug Low Nov 29, 2023

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By L…

NCS Healthcare of Kentucky Inc

FDA Drug Critical Nov 29, 2023

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, …

Cardinal Health Inc.

FDA Drug Moderate Nov 29, 2023

Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100…

Integrity Bio-Chemicals LLC

FDA Drug Critical Nov 29, 2023

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b)…

Exela Pharma Sciences LLC

FDA Drug Low Nov 29, 2023

Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only,…

NCS Healthcare of Kentucky Inc

FDA Drug Moderate Nov 29, 2023

Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 N…

Integrity Bio-Chemicals LLC

FDA Drug Critical Nov 29, 2023

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

FDA Drug Moderate Nov 29, 2023

Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 N…

Integrity Bio-Chemicals LLC

FDA Drug Low Nov 29, 2023

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10…

Glenmark Pharmaceuticals Inc., USA

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio…

Cardinal Health Inc.

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, D…

Cardinal Health Inc.

FDA Drug Critical Nov 29, 2023

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI …

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

FDA Drug Critical Nov 29, 2023

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion O…

Exela Pharma Sciences LLC

FDA Drug Moderate Nov 22, 2023

Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

Omega & Delta Co., Inc.

FDA Drug Moderate Nov 22, 2023

Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W C…

Family Medical Supply Inc

FDA Drug Moderate Nov 15, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed …

Zydus Pharmaceuticals (USA) Inc

FDA Drug Critical Nov 15, 2023

2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distrib…

Pfizer Inc.

FDA Drug Moderate Nov 15, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed…

Zydus Pharmaceuticals (USA) Inc

FDA Drug Critical Nov 15, 2023

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx on…

Pfizer Inc.

FDA Drug Moderate Nov 15, 2023

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distri…

PAR Sterile Products LLC

FDA Drug Moderate Nov 15, 2023

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC…

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Nov 15, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed…

Zydus Pharmaceuticals (USA) Inc

FDA Drug Moderate Nov 15, 2023

Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medlin…

MEDLINE INDUSTRIES, LP - Northfield

FDA Drug Low Nov 15, 2023

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 6934…

Zyla Life Sciences US Inc.

FDA Drug Critical Nov 15, 2023

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distribu…

Pfizer Inc.

FDA Drug Moderate Nov 8, 2023

Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactu…

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Nov 8, 2023

Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufact…

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Low Nov 8, 2023

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmac…

Edenbridge Pharmaceuticals, LLC

FDA Drug Low Nov 1, 2023

VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, …

Denver Solutions, LLC DBA Leiters Health

FDA Drug Critical Nov 1, 2023

ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA Drug Low Nov 1, 2023

VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, N…

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Nov 1, 2023

Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA Drug Low Nov 1, 2023

Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, …

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Nov 1, 2023

ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA Drug Low Nov 1, 2023

Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.…

West-Ward Columbus 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

Category data as of Jun 3, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for drugs & medications. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jun 3, 2026.