PlainRecalls

Product category · Updated Jun 3, 2026

Drugs & Medications recalls

Prescription and over-the-counter medication recalls

Total recalls
14,058
Top agency
FDA Drug
Years covered
2000–2026
Compiled from official public sources by the editorial team.
Check a product → All categories

Drugs & Medications accounts for 14,058 recalls — about 14.0% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 14,058 drugs & medications recalls between 2000 and 2026 — roughly 14.0% of the 100,165-record archive. Of the 14,058 records graded for severity, 9% are high-severity. Most are issued by FDA Drug. Counts reflect market size and reporting activity, not a product's inherent danger.

  • 14,058 total recalls
  • 14.0% of the archive
  • 9% graded high-severity
  • FDA Drug top agency

Category snapshot

Drugs & Medications accounts for 14,058 recalls — about 14.0% of the 100,165-record federal archive, with 1,277 graded high-severity, most issued by FDA Drug.

14,058
total recalls
9%
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 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 1797 1025 953 1253 1406 756 706 1080 904 555 658 216

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 90 of 282

FDA Drug Critical Jul 8, 2020

Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, Ma…

MasterPharm LLC
FDA Drug Moderate Jul 8, 2020

Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Ph…

Preferred Pharmaceuticals, Inc.
FDA Drug Moderate Jul 8, 2020

Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 9…

Beaming White Llc
FDA Drug Moderate Jul 1, 2020

Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Ma…

Teva Pharmaceuticals USA
FDA Drug Moderate Jul 1, 2020

Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7…

Marksans Pharma Limited
FDA Drug Low Jul 1, 2020

Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus…

American Health Packaging
FDA Drug Low Jul 1, 2020

Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distribu…

Pfizer Inc.
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial

BIOTA Biosciences LLC
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewa…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Low Jul 1, 2020

Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, I…

Rising Pharmaceuticals, Inc.
FDA Drug Moderate Jul 1, 2020

Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor…

Aurobindo Pharma USA Inc.
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgew…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC…

Crown Laboratories
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC …

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD M…

Lupin Pharmaceuticals Inc.
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Low Jul 1, 2020

Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Bro…

Rising Pharmaceuticals, Inc.
FDA Drug Moderate Jul 1, 2020

Sterile Curcumin 50mg/mL, 10 mL vial

BIOTA Biosciences LLC
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, N…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

Sterile Curcumin, 4mg/mL, 10mL vial

BIOTA Biosciences LLC
FDA Drug Moderate Jul 1, 2020

Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 3893…

Alembic Pharmaceuticals Limited
FDA Drug Moderate Jul 1, 2020

Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial

BIOTA Biosciences LLC
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedab…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Wat…

Teva Pharmaceuticals USA
FDA Drug Moderate Jul 1, 2020

Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial

BIOTA Biosciences LLC
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahm…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72…

PD-Rx Pharmaceuticals, Inc.
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewate…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. …

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewa…

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. …

Amneal Pharmaceuticals of New York, LLC
FDA Drug Moderate Jul 1, 2020

Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC …

Crown Laboratories
FDA Drug Low Jun 24, 2020

Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma…

Aurobindo Pharma USA Inc.
FDA Drug Moderate Jun 24, 2020

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 7000…

SCA Pharmaceuticals
FDA Drug Moderate Jun 24, 2020

metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets …

PD-Rx Pharmaceuticals, Inc.
FDA Drug Moderate Jun 24, 2020

EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, …

Eco Lips Inc
FDA Drug Moderate Jun 24, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291…

AVKARE Inc.
FDA Drug Moderate Jun 24, 2020

Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Dist…

Hikma Pharmaceuticals USA Inc.
FDA Drug Moderate Jun 24, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T…

Apotex Inc.
FDA Drug Low Jun 24, 2020

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma…

Aurobindo Pharma USA Inc.
FDA Drug Moderate Jun 24, 2020

Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Dis…

Hikma Pharmaceuticals USA Inc.
FDA Drug Moderate Jun 24, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-6…

AVKARE Inc.
FDA Drug Critical Jun 17, 2020

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC…

Fresenius Kabi USA, LLC
FDA Drug Low Jun 17, 2020

Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04

Akorn, Inc.
FDA Drug Low Jun 17, 2020

Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bard…

UNICHEM PHARMACEUTICALS USA INC
FDA Drug Moderate Jun 17, 2020

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100…

QuVa Pharma, Inc.
FDA Drug Moderate Jun 17, 2020

Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin …

Lupin Pharmaceuticals Inc.
FDA Drug Moderate Jun 17, 2020

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vi…

Fresenius Kabi USA, LLC
FDA Drug Moderate Jun 17, 2020

Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfize…

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.

Medical Devices

40,478 recalls →

Food

25,527 recalls →

Vehicles

10,474 recalls →

Children & Baby Products

3,395 recalls →

Household Products

2,800 recalls →

Cosmetics & Personal Care

1,057 recalls →

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.