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
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 64 of 282

FDA Drug Moderate Feb 16, 2022

Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-32…

ULTRAtab Laboratories, Inc.

FDA Drug Critical Feb 16, 2022

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

Esupplementsales, LLC

FDA Drug Moderate Feb 16, 2022

3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 9, 2022

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Bal…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Dir…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus …

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dic…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Ra…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, A…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Pro…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the U…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 4…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributo…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woo…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dic…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC …

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dic…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist.…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, …

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufacture…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

Ultra Seal Corporation

FDA Drug Low Feb 9, 2022

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories,…

Teva Pharmaceuticals USA

FDA Drug Moderate Feb 9, 2022

CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. …

Ultra Seal Corporation

FDA Drug Low Feb 9, 2022

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories…

Teva Pharmaceuticals USA

FDA Drug Moderate Feb 9, 2022

Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co.,…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Indus…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC …

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA

Ultra Seal Corporation

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.