Acetaminophen recalls: 36 FDA reports
Recalls involving Acetaminophen. What was wrong with each batch, and how the FDA graded the risk.
36Reports
3Class I
7Ongoing
2025-11-05Most recent
3 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc
D-0121-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Defective Container
- Product
- TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.
- Where it went
- U.S. Nationwide - CO, IL, OH and IN.
- How much
- 3,816 bottles
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Health
D-0596-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Discoloration
- Product
- 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 Ireland, NDC 36000-306-60.
- Where it went
- U.S.A. Nationwide
- How much
- 13,000 containers
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N.
D-0471-2025 · Class II · reported 2025-06-25 · Ongoing
- Why it was recalled
- cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- Product
- Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
- Where it went
- USA Nationwide.
- How much
- 4,608 bottles
Class I
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx
D-0635-2024 · Class I · reported 2024-08-28 · Ongoing
- Why it was recalled
- Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
- Product
- Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
- Where it went
- OH and PR
- How much
- 31,400 bags
Class I
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, L
D-0631-2024 · Class I · reported 2024-08-14 · Terminated
- Why it was recalled
- Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
- Product
- Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
- Where it went
- Nationwide within the United States.
- How much
- 429 bottles
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N L
D-0566-2024 · Class II · reported 2024-07-03 · Ongoing
- Why it was recalled
- Discoloration: Brownish tablets
- Product
- Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606
- Where it went
- MI
- How much
- 14,616 bottles
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor
D-0143-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698.
- Where it went
- Nationwide
- How much
- 376,370 bottles
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4
D-0142-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.
- Where it went
- Nationwide
- How much
- 591,684 bottles
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distribute
D-0765-2023 · Class II · reported 2023-05-31 · Completed
- Why it was recalled
- Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
- Product
- Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.
- Where it went
- The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
- How much
- 87,360 bottles
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For In
D-1348-2022 · Class II · reported 2022-08-24 · Terminated
- Why it was recalled
- Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
- Product
- Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
- Where it went
- Nationwide in the USA
- How much
- 85,680 bags
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distribute
D-0601-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26
- Where it went
- Nationwide in the USA
- How much
- 4,992 bottles
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle,
D-0580-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26
- Where it went
- Nationwide in the USA
- How much
- 117552 bottles
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY:
D-0598-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16
- Where it went
- Nationwide in the USA
- How much
- 68,688 bottles
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distribut
D-0587-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-26
- Where it went
- Nationwide in the USA
- How much
- 2,832 bottles
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distribute
D-0602-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26
- Where it went
- Nationwide in the USA
- How much
- 3,024 bottles
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUT
D-0588-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26
- Where it went
- Nationwide in the USA
- How much
- 20,448 bottles
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Ta
D-0584-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16
- Where it went
- Nationwide in the USA
- How much
- 22,140 bottles
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUT
D-0589-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC: 49035-959-26
- Where it went
- Nationwide in the USA
- How much
- 30,144 bottles
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed
D-0581-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97
- Where it went
- Nationwide in the USA
- How much
- 4,992 bottles
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY TH
D-0596-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16
- Where it went
- Nationwide in the USA
- How much
- 5,184 bottles
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED
D-0590-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC: 55910-251-26
- Where it went
- Nationwide in the USA
- How much
- 16,992 bottles
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed
D-0592-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26
- Where it went
- Nationwide in the USA
- How much
- 111,888 bottles
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: W
D-0597-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16
- Where it went
- Nationwide in the USA
- How much
- 55,656 bottles
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUT
D-0586-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202. NDC: 30142-818-26
- Where it went
- Nationwide in the USA
- How much
- 3,120 bottles
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed
D-0591-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26
- Where it went
- Nationwide in the USA
- How much
- 26,832 bottles
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack,
D-0599-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26
- Where it went
- Nationwide in the USA
- How much
- 83760 packs
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY TH
D-0595-2022 · Class II · reported 2022-03-02 · Terminated
- Why it was recalled
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Product
- Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16
- Where it went
- Nationwide in the USA
- How much
- 1,296 bottles
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-5
D-0095-2022 · Class II · reported 2021-11-17 · Terminated
- Why it was recalled
- cGMP Deviations: Product manufactured with contaminated raw ingredient.
- Product
- Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
- Where it went
- Nationwide USA
- How much
- 151,100 unit dose cups
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a)
D-0094-2022 · Class II · reported 2021-11-17 · Terminated
- Why it was recalled
- cGMP Deviations: Product manufactured with contaminated raw ingredient.
- Product
- Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
- Where it went
- Nationwide USA
- How much
- 166,920 unit dose cups
Class I
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Li
D-0358-2021 · Class I · reported 2021-05-12 · Terminated
- Why it was recalled
- Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
- Product
- Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves.
- Where it went
- Nationwide in the USA
- How much
- 201,600 kits
Showing the 30 most recent of 36. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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