Acetaminophen (Tylenol) recalls
FDA drug recall list
Acetaminophen products, including store brands of Tylenol, are recalled for labeling errors, contamination, or packaging that isn't child-resistant.
FDA data updated Last synced
- Reports mentioning it
- 240
- Class I (serious)
- 15
- Class II
- 182
- Class III
- 43
Key facts: acetaminophen (Tylenol) recalls
- The FDA has published 240 drug enforcement reports mentioning acetaminophen (Tylenol) since 2012, as of October 7, 2026.
- 15 of them were Class I, the most serious category, where a product could cause serious health problems or death.
- The most recent was reported on Jan 14, 2026: Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx… (SpecGx, LLC), Class II.
- Source: U.S. Food and Drug Administration enforcement reports via openFDA. See our sources policy.
Latest 150 acetaminophen (Tylenol) recalls
- Jan 14, 2026Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx…Drug · SpecGx, LLCFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.Class II
- Jan 14, 2026Oxycodone and Acetaminophen CII Tablets USP, 7Drug · SpecGx, LLCFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.Class II
- Nov 12, 2025Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further pac…Drug · Aero HealthcareLabeling: 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…Class II
- Nov 5, 2025TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson…Drug · Kenvue Brands LLCDefective ContainerClass II
- Sep 3, 2025Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container,…Drug · Baxter Healthcare CorporationDiscolorationClass II
- Jun 25, 2025Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: AmazonDrug · Aurobindo Pharma USA InccGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).Class II
- Apr 16, 2025Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a)Drug · Glenmark Pharmaceuticals Inc., USACGMP DeviationsClass II
- Jan 22, 2025Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for:…Drug · Akron Pharma, Inc.Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Class III
- Jan 22, 2025Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, IncDrug · Akron Pharma, Inc.Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Class III
- Jan 22, 2025Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, IncDrug · Akron Pharma, Inc.Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.Class III
- Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufacture…
- Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/…
- Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For I…
- Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Ge…
- Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S…
- Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHA…
- Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packa…
- Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), pa…
- Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg…
- Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20…
- KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension…
- KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, O…
- Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bo…
- Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardb…
- Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg…
- NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER D…
- Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 t…
- Acetaminophen Oral Solution, 325 mg / 10
- CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per…
- Acetaminophen Oral Solution 650 mg / 20
- Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559
- Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399…
- Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01)
- Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single…
- Acetaminophen Oral Solution, USP 650mg/ 20
- Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL)…
- Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl…
- Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per…
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL…
- Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bott…
- Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bott…
- Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL)…
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL…
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bo…
- Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per…
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL…
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) p…
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bo…
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) p…
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) p…
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bo…
- Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bott…
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL…
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) p…
- Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118…
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bo…
- Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bott…
- Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL)…
- Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack
- APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc
- Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laborat…
- Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg)…
- Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Lab…
- Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Labor…
- 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 1…
- HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32
- Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine…
- Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laborat…
- Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Lab…
- 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg)…
- Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories,…
- Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc
- APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc
- APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Labo…
- Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Co…
- Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1
- Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc
- APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc
- APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Co…
- Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTR…
- Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephr…
- Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg…
- COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5
- AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2…
- Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 table…
- Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in…
- Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets…
- PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicy…
- Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manu…
- DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5…
- FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packet…
- Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin…
- PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc
- Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tab…
- PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffe…
- Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, sa…
- Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet pack…
- CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenyleph…
- Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg cap…
- Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenyl…
- PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets…
- PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32
- CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets,…
- Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet…
- Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured…
- EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist
- Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32
- SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5
- Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifene…
- AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist
- Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32
- Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 3…
- CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15…
- Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd
- Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffe…
- Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets,…
- Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablet…
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, R…
- Acetaminophen Oral Suspension, 325 mg/10
- Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cu…
- Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tabl…
- Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Ca…
- Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets,…
- ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID),…
- AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2…
- North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, C…
- Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine…
- PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk…
- Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distrib…
- Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated T…
- Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20…
- Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Ma…
- Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For In…
- Benzhydrocodone and Acetaminophen Tablets, CII, 6
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx…
- Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) table…
- Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tab…
- Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (…
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx O…
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx O…
- Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Dist…
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx O…
- Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42…
- Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, package…
- Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-cou…
- Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Phar…
- Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin…
- Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspi…
- Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol f…
- DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measure…
Showing the 150 most recent recalls of acetaminophen (Tylenol) products. 240 FDA reports mention acetaminophen (Tylenol) in total, including as an ingredient in other products. Use the search on the homepage to look up a specific brand or lot number.
Questions about acetaminophen (Tylenol) recalls
Is there an acetaminophen (Tylenol) recall right now?
There are no new FDA acetaminophen (Tylenol) recall reports in the last 90 days as of October 7, 2026. The most recent was “Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx…” from SpecGx, LLC (Class II), reported Jan 14, 2026. FDA reports can appear weeks after a recall starts, so also check the FDA's official recall notices.
What should I do with a recalled acetaminophen (Tylenol) product?
If you have a recalled acetaminophen (Tylenol) product, compare the lot number and expiration date with the recall. Don't stop taking a prescription medicine on your own: call your pharmacist or doctor, who can confirm whether your supply is affected and arrange a replacement. In an emergency, call 911 or Poison Control at 1-800-222-1222.
How do I know if my acetaminophen (Tylenol) product is part of the recall?
Open the recall in the list on this page and compare the brand, product size, lot or UPC code, and best-by or expiration date with your package. A match on the product name alone doesn't mean your item is affected. You can also search by lot number on the FindMyRecall homepage.
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