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 12 of 286

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

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

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

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pith…

Cipla USA, Inc.

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

PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL b…

Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

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.

FDA Drug Moderate Jul 23, 2025

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 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, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend…

Ascend Laboratories, LLC

FDA Drug Moderate Jul 23, 2025

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufa…

ACCORD HEALTHCARE, INC.

FDA Drug Low Jul 16, 2025

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Lt…

Macleods Pharmaceuticals Ltd

FDA Drug Moderate Jul 16, 2025

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spai…

Breckenridge Pharmaceutical, Inc.

FDA Drug Critical Jul 9, 2025

Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Pr…

Sandoz Inc

FDA Drug Low Jul 9, 2025

Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufa…

Orient Pharma Co., Ltd. Yunlin Plant

FDA Drug Moderate Jul 9, 2025

KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, …

Tailstorm Health INC

FDA Drug Moderate Jul 9, 2025

LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural…

Tailstorm Health INC

FDA Drug Critical Jul 9, 2025

Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sand…

Sandoz Inc

FDA Drug Moderate Jul 9, 2025

KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compou…

Tailstorm Health INC

FDA Drug Moderate Jul 9, 2025

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapol…

The Harvard Drug Group LLC

FDA Drug Moderate Jul 9, 2025

BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block,…

Tailstorm Health INC

FDA Drug Critical Jul 9, 2025

ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5

Church & Dwight Inc

FDA Drug Moderate Jul 9, 2025

LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & …

Tailstorm Health INC

FDA Drug Moderate Jul 9, 2025

LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Fre…

Tailstorm Health INC

FDA Drug Low Jul 9, 2025

Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufa…

Orient Pharma Co., Ltd. Yunlin Plant

FDA Drug Critical Jul 9, 2025

ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6

Church & Dwight Inc

FDA Drug Moderate Jul 9, 2025

Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 US…

The Harvard Drug Group LLC

FDA Food Low Jul 2, 2025

Rodex Forte, dietary supplement. 90 capsule bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)

Preventics, Inc. dba Legere Pharmaceuticals

FDA Food Low Jul 2, 2025

Protrim Plus, dietary supplement. 90 capsule/bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)

Preventics, Inc. dba Legere Pharmaceuticals

FDA Drug Moderate Jul 2, 2025

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: …

Apotex Corp.

FDA Drug Moderate Jul 2, 2025

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC…

Fresenius Medical Care Holdings, Inc.

FDA Drug Moderate Jul 2, 2025

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Cor…

Apotex Corp.

FDA Drug Moderate Jul 2, 2025

TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, AD…

Advanced Pharmaceutical Technology, Inc.

FDA Drug Moderate Jul 2, 2025

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made…

Pfizer 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.