Ibuprofen recalls: 26 FDA reports
Recalls involving Ibuprofen. What was wrong with each batch, and how the FDA graded the risk.
26Reports
0Class I
5Ongoing
2026-03-25Most recent
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.
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pha
D-0390-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
- Product
- Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
- Where it went
- U.S.A. Nationwide
- How much
- 89592 bottles
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Prince
D-0047-2025 · Class III · reported 2024-11-27 · Ongoing
- Why it was recalled
- Failed Tablet/Capsule Specifications
- Product
- IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
- Where it went
- USA Nationwide
- How much
- 3416 botttles
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540,
D-0644-2024 · Class II · reported 2024-09-04 · Ongoing
- Why it was recalled
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Product
- IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 103,298 bottles
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540,
D-0646-2024 · Class II · reported 2024-09-04 · Ongoing
- Why it was recalled
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Product
- IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 14940 bottles
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540,
D-0645-2024 · Class II · reported 2024-09-04 · Ongoing
- Why it was recalled
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Product
- IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 31,802 bottles
Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61
D-1055-2022 · Class II · reported 2022-06-15 · Terminated
- Why it was recalled
- cGMP deviations: Temperature abuse
- Product
- Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61
- Where it went
- USA nationwide.
- How much
- 1 carton/100 blisters per carton
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl
D-0065-2021 · Class III · reported 2020-11-11 · Terminated
- Why it was recalled
- Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
- Product
- Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92
- Where it went
- NJ
- How much
- 7440 bottles
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1
D-1066-2020 · Class II · reported 2020-04-01 · Terminated
- Why it was recalled
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Product
- Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
- Where it went
- Product was distributed throughout the United States, including Puerto Rico.
- How much
- 446,628 bottles
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. b
D-1067-2020 · Class II · reported 2020-04-01 · Terminated
- Why it was recalled
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Product
- Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
- Where it went
- Product was distributed throughout the United States, including Puerto Rico.
- How much
- 151,056 bottles
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals
D-0299-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9
- Where it went
- U.S.A. Nationwide
- How much
- 639,325 bottles
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(24
D-0301-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1
- Where it went
- U.S.A. Nationwide
- How much
- 5,190 bottles
Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceutical
D-0298-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8
- Where it went
- U.S.A. Nationwide
- How much
- 138,886 bottles
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (12
D-0300-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Product
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
- Where it went
- U.S.A. Nationwide
- How much
- 182,986 bottles
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madiso
D-1169-2018 · Class II · reported 2018-09-05 · Terminated
- Why it was recalled
- Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
- Product
- Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
- Where it went
- Nationwide within the United States
- How much
- 17,136 bottles
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, R
D-0692-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
- Where it went
- Nationwide.
- How much
- N/A
Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, R
D-0687-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
- Where it went
- Nationwide.
- How much
- N/A
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), R
D-0689-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
- Where it went
- Nationwide.
- How much
- N/A
Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tabl
D-0686-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
- Where it went
- Nationwide.
- How much
- N/A
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 capl
D-0694-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
- Where it went
- Nationwide.
- How much
- N/A
Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 t
D-0685-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
- Where it went
- Nationwide.
- How much
- N/A
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500
D-0695-2018 · Class II · reported 2018-05-02 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
- Where it went
- Nationwide.
- How much
- N/A
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma,
D-0583-2018 · Class II · reported 2018-03-14 · Terminated
- Why it was recalled
- CGMP deviations: Ibuprofen is being recalled in response to previous recall
- Product
- Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
- Where it went
- NY
- How much
- 144 bottles
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper
D-0235-2018 · Class II · reported 2018-01-31 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.
- Where it went
- Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
- How much
- 2,853,500 Caplets
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packag
D-0237-2018 · Class II · reported 2018-01-31 · Terminated
- Why it was recalled
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Product
- Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.
- Where it went
- Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
- How much
- 205,088,000 tablets
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, In
D-1055-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
- Product
- Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50
- Where it went
- Nationwide U.S.A.
- How much
- 1,980 bottles
IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Redd
D-1042-2013 · Class II · reported 2013-09-25 · Terminated
- Why it was recalled
- Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
- Product
- IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.
- Where it went
- Nationwide (& Puerto Rico)
- How much
- 18852 bottles
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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