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 84 of 282

FDA Drug Low Dec 23, 2020

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

SCA Pharmaceuticals
CPSC Moderate Dec 23, 2020

GSK Consumer Health Recalls Five Excedrin Brands Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

GSK Consumer Healthcare, of Warren, N.J.
FDA Drug Moderate Dec 16, 2020

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Sh…

Shilpa Medicare Limited
FDA Drug Moderate Dec 16, 2020

Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals In…

Shilpa Medicare Limited
FDA Drug Low Dec 16, 2020

Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured…

Novocol Pharmaceutical of Canada, Inc.
FDA Drug Moderate Dec 16, 2020

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Sh…

Shilpa Medicare Limited
FDA Drug Moderate Dec 16, 2020

Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa…

Shilpa Medicare Limited
FDA Drug Moderate Dec 16, 2020

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx O…

Shilpa Medicare Limited
FDA Drug Critical Dec 16, 2020

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, …

Fresenius Kabi USA, LLC
FDA Drug Moderate Dec 16, 2020

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals In…

Shilpa Medicare Limited
FDA Drug Moderate Dec 16, 2020

Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI …

Asiaticon, SA de CV
FDA Drug Critical Dec 9, 2020

Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01

Torrent Pharma Inc
FDA Drug Moderate Dec 9, 2020

ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, …

Golden State Medical Supply Inc.
FDA Drug Low Dec 9, 2020

Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60

Teligent Pharma, Inc.
FDA Drug Moderate Dec 9, 2020

CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC…

US Pharmaceuticals Inc.
FDA Drug Moderate Dec 9, 2020

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distribute…

The Harvard Drug Group
FDA Drug Moderate Dec 9, 2020

Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend…

Ascend Laboratories LLC
FDA Drug Low Dec 9, 2020

Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10…

InvaTech Pharma Solutions, LLC
FDA Drug Critical Dec 9, 2020

REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-…

MPM Medical LLC
FDA Drug Low Dec 2, 2020

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59

Teligent Pharma, Inc.
FDA Drug Moderate Dec 2, 2020

clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC …

Jubilant Cadista Pharmaceuticals, Inc.
FDA Drug Low Dec 2, 2020

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lak…

Fresenius Kabi USA, LLC
FDA Drug Moderate Dec 2, 2020

Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health an…

Fusion Health and Vitality LLC
FDA Drug Moderate Dec 2, 2020

Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Ma…

EYWA PHARMA INC
FDA Drug Low Dec 2, 2020

Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made…

Heritage Pharmaceuticals Inc
FDA Drug Critical Dec 2, 2020

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL)…

Sunstar Americas, Inc.
FDA Drug Moderate Nov 25, 2020

Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactu…

Apotex Corp.
FDA Drug Moderate Nov 25, 2020

Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788…

Preferred Pharmaceuticals, Inc.
FDA Drug Moderate Nov 25, 2020

Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads

Milbar Laboratories, Inc.
FDA Drug Moderate Nov 25, 2020

Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-…

Hikma Pharmaceuticals USA Inc.
FDA Drug Moderate Nov 25, 2020

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscata…

Ascent Pharmaceuticals, Inc.
FDA Drug Low Nov 25, 2020

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-32…

Teva Pharmaceuticals USA
FDA Drug Moderate Nov 25, 2020

(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Milbar Laboratories, Inc.
FDA Drug Moderate Nov 25, 2020

(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Dis…

Milbar Laboratories, Inc.
FDA Drug Moderate Nov 18, 2020

Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway,…

H & H Remedies, LLC
FDA Drug Moderate Nov 18, 2020

Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 4229…

AVKARE Inc.
FDA Drug Moderate Nov 18, 2020

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, …

Teva Pharmaceuticals USA
FDA Drug Moderate Nov 18, 2020

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter…

Baxter Healthcare Corporation
FDA Drug Moderate Nov 18, 2020

Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David …

H & H Remedies, LLC
FDA Drug Moderate Nov 11, 2020

Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 c…

Marksans Pharma Limited
FDA Drug Moderate Nov 11, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO…

Nostrum Laboratories Inc
FDA Drug Moderate Nov 11, 2020

metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC…

PD-Rx Pharmaceuticals, Inc.
FDA Drug Moderate Nov 11, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO…

Nostrum Laboratories Inc
FDA Drug Low Nov 11, 2020

Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, I…

Jubilant Cadista Pharmaceuticals, Inc.
FDA Drug Moderate Nov 11, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-…

Denton Pharma, Inc.
FDA Drug Moderate Nov 11, 2020

Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0

Medichem S.A.
FDA Drug Moderate Nov 11, 2020

Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 M…

Marksans Pharma Limited
FDA Drug Moderate Nov 11, 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: 72789…

PD-Rx Pharmaceuticals, Inc.
FDA Drug Low Nov 11, 2020

Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60,…

Teligent Pharma, Inc.
FDA Drug Low Nov 11, 2020

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed…

Aurobindo Pharma USA 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.