Is Tylenol recalled?

OTC medicine · checked against 7 official databases (US · Canada · UK) · newest matching record: December 26, 2025

FDA food enforcement US

No matching records.

FDA drug enforcement US

• TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CTClass II
  Dec 26, 2025 · GOLD STAR DISTRIBUTION INC
  CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
  View official record →
• Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.Class II
  Dec 16, 2025 · SpecGx, LLC
  Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
  View official record →
• Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx L…Class II
  Dec 16, 2025 · SpecGx, LLC
  Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
  View official record →
• TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Wash…Class II
  Oct 21, 2025 · Kenvue Brands LLC
  Defective Container
  View official record →
• Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, …Class II
  Oct 17, 2025 · Aero Healthcare
  Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSA…
  View official record →
• Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ir…Class II
  Aug 20, 2025 · Baxter Healthcare Corporation
  Discoloration
  View official record →
• Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10Class II
  May 22, 2025 · Aurobindo Pharma USA Inc
  cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
  View official record →
• Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glen…Class II
  Mar 13, 2025 · Glenmark Pharmaceuticals Inc., USA
  CGMP Deviations
  View official record →
• Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.Class III
  Dec 12, 2024 · Akron Pharma, Inc.
  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
  View official record →
• Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-0…Class III
  Dec 12, 2024 · Akron Pharma, Inc.
  Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
  View official record →

FDA device enforcement US

• ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL…Class II
  Apr 5, 2023 · Siemens Healthcare Diagnostics, Inc.
  Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
  View official record →
• Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 2…Class II
  Mar 11, 2022 · Total Resources Intl
  ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system bre…
  View official record →
• First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)Class II
  Mar 2, 2022 · ASO LLC
  Kits contained recalled acetaminophen.
  View official record →
• Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 testClass II
  Jan 2, 2018 · Roche Diagnostics Corporation
  The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interfere…
  View official record →
• Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B p…Class II
  Dec 11, 2017 · Sanofi Genzyme
  Contamination with Methylbacterium thiocyanatum
  View official record →
• Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Se…Class II
  Jul 20, 2017 · Beckman Coulter Inc.
  Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
  View official record →
• Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30:…Class II
  Jan 22, 2016 · Sekisui Diagnostics P.E.I. Inc.
  Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
  View official record →
• ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium hepar…Class II
  Jun 30, 2015 · Siemens Healthcare Diagnostics, Inc.
  A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.
  View official record →
• Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit b…Class II
  Feb 5, 2014 · Alere San Diego, Inc.
  Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negativ…
  View official record →
• VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET…Class II
  Jun 12, 2013 · Ortho-Clinical Diagnostics
  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
  View official record →

CPSC consumer products US

• Aurohealth Recalls Kroger Brand Acetaminophen Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
  Jun 16, 2022 · Aurobindo Pharma Limited, of Telangana, India
  The recalled over-the-counter product contains the regulated substance acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is…
  View official record →
• Aurohealth Recalls Walgreens Brand Acetaminophen Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
  Jun 16, 2022 · Aurobindo Pharma Limited, of Telangana, India
  The recalled over-the-counter products contain the regulated substance acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is…
  View official record →
• Sun Pharma Recalls Kroger Brand Acetaminophen Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
  Jun 16, 2022 · Sun Pharmaceutical Industries Inc., of Princeton, New Jersey
  The recalled over-the-counter product contains the regulated substance acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is …
  View official record →

Health Canada / CFIA / Transport Canada CA

• Children's Tylenol Acetaminophen Suspension - Dye Free Soothing Berry
  date at source · Drugs and health products
  Product safety
  View official record →
• Important Safety Information on Tylenol with Codeine in Nursing Mothers and Ultra-Rapid Metabolizers of Codeine - For Health Professionals
  date at source · Marketed health products
  View official record →
• Updated Information Regarding Recalled Infant and Children Motrin and Tylenol Products
  date at source · Communications and Public Affairs Branch
  Product quality
  View official record →
• Archived – TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP
  date at source · Communications and Public Affairs Branch
  Contamination - Product safety
  View official record →
• Acetaminophen is a recommended treatment for fever and pain during pregnancy
  date at source · Communications and Public Affairs Branch
  Product safety
  View official record →
• JAMP-ASA 81MG EC: may contain foreign tablets containing acetaminophen and methocarbamol
  date at source · Drugs and health products
  Product safety
  View official record →
• Riva Acetaminophen 500mg : Affected lot may contain 325mg Acetaminophen tablets
  date at source · Drugs and health products
  Product quality
  View official record →
• Jamp-Acetaminophen tablet: Overweight & Underweight tablets
  date at source · Drugs and health products
  Product quality
  View official record →
• Pediatrix Acetaminophen Oral Solution for children: One lot recalled due to potential risk of overdose
  date at source · Communications and Public Affairs Branch
  Product safety
  View official record →
• JAMP Acetaminophen 325: Product Quality
  date at source · Drugs and health products
  Product quality
  View official record →

UK OPSS product safety UK

No matching records.

UK Food Standards Agency UK

No matching records.

Related federal court cases via CourtListener

22 product-liability or consumer-fraud dockets in federal court name Tylenol or a related entity — some are class actions, others individual suits. Newest first.

• Amado v. Kenvue Brands LLC370 Other Fraud
  Filed 2026-05-07 · open · N.D. Cal. · No. 3:26-cv-04204
  View docket →
• BEYER v. KENVUE BRANDS LLC370 Other Fraud
  Filed 2025-06-26 · open · D.N.J. · No. 2:25-cv-12180
  View docket →
• Badilla v. Kenvue Inc.370 Other Fraud
  Filed 2024-11-15 · closed 2025-01-22 · D.N.J. · No. 3:24-cv-10521
  View docket →
• Alan Montenegro v. Johnson and Johnson Consumer, Inc.370 Other Fraud
  Filed 2024-09-17 · closed 2025-04-28 · D.N.J. · No. 3:24-cv-09226
  View docket →
• Jones v. Kenvue, Inc.365 Personal Inj. Prod. Liability
  Filed 2024-07-31 · closed 2024-08-20 · W.D. Mo. · No. 4:24-cv-00499
  View docket →
• Badilla v. Kenvue Inc.370 Fraud or Truth-In-Lending
  Filed 2024-07-05 · closed 2024-11-07 · E.D.N.Y · No. 1:24-cv-04710
  View docket →

Court filings are allegations, not findings of fault or safety determinations. Cases are matched by party name and may involve unrelated products. This is public-record information, not legal advice.