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 161 of 282

FDA Drug Moderate May 31, 2017

Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Low May 31, 2017

Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Hal…

Sun Pharmaceutical Industries, Inc.
FDA Drug Moderate May 31, 2017

Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Low May 31, 2017

HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785…

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
FDA Drug Moderate May 31, 2017

Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Moderate May 31, 2017

Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Moderate May 31, 2017

DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakas…

Sato Pharmaceutical Inc.
FDA Drug Moderate May 31, 2017

NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Moderate May 31, 2017

SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LT…

Sato Pharmaceutical Inc.
FDA Drug Moderate May 31, 2017

Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research…

GlaxoSmithKline, LLC
FDA Drug Moderate May 31, 2017

Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Moderate May 31, 2017

Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Critical May 31, 2017

LaBri's Body Health Atomic, 60 capsules

Envy Me
FDA Drug Moderate May 31, 2017

Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Critical May 31, 2017

Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X H…

Standard Homeopathic Company
FDA Drug Moderate May 31, 2017

Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Moderate May 31, 2017

Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Moderate May 31, 2017

Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Moderate May 31, 2017

Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Advanced Pharma Inc.
FDA Drug Low May 24, 2017

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist.…

Taro Pharmaceuticals U.S.A., Inc.
FDA Drug Moderate May 24, 2017

PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfiel…

Baxter Healthcare Corporation
FDA Drug Moderate May 24, 2017

ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pha…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Ph…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Comp…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2M…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Ph…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharm…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key C…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compoundin…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Comp…

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center
FDA Drug Moderate May 24, 2017

HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center

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.