Ibuprofen recalls
FDA drug recall list
Ibuprofen recalls include tablets with the wrong strength and liquids for children with dosing problems. Check the lot number on the bottle.
FDA data updated Last synced
- Reports mentioning it
- 68
- Class I (serious)
- 5
- Class II
- 60
- Class III
- 3
Key facts: ibuprofen recalls
- The FDA has published 68 drug enforcement reports mentioning ibuprofen since 2012, as of October 7, 2026.
- 5 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 Mar 25, 2026: Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Man… (STRIDES PHARMA INC), Class II.
- Source: U.S. Food and Drug Administration enforcement reports via openFDA. See our sources policy.
Latest 65 ibuprofen recalls
- Mar 25, 2026Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Man…Drug · STRIDES PHARMA INCPresence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.Class II
- Jan 21, 2026Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual pa…Drug · GOLD STAR DISTRIBUTION INCCGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Class II
- Apr 16, 2025Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a)Drug · Glenmark Pharmaceuticals Inc., USACGMP DeviationsClass II
- Nov 27, 2024IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: DrDrug · Dr. Reddy's Laboratories, Inc.Failed Tablet/Capsule SpecificationsClass III
- Nov 13, 2024Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Pac…Drug · Direct RxFailed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.Class II
- Sep 4, 2024IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: DrDrug · Dr. Reddy's Laboratories, Inc.Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.Class II
- Sep 4, 2024Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: DrDrug · Preferred Pharmaceuticals, Inc.Failed Impurities/Degradation Specifications - at 18-month Stability testingClass II
- Sep 4, 2024IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: DrDrug · Dr. Reddy's Laboratories, Inc.Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.Class II
- Sep 4, 2024IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: DrDrug · Dr. Reddy's Laboratories, Inc.Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.Class II
- Jan 24, 2024Ibuprofen and Famotidine Tablets 800mg/26Drug · Ascend Laboratories, LLCPresence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.Class II
- Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
- Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg…
- Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-…
- Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NS…
- Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Re…
- Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (N…
- Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60…
- Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma
- IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML
- Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Relie…
- Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0…
- Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets
- Ibuprofen 50 mg per 1
- Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl
- Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured b…
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alco…
- Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alco…
- Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alco…
- infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1
- Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1
- Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1
- infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1
- Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1
- Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1
- Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml)…
- Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 4…
- Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 4…
- Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottl…
- Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (…
- Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottle…
- Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 539…
- Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 494…
- Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by…
- Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 4…
- Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC-…
- Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 534…
- Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceu…
- PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24
- Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper p…
- Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in…
- Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper p…
- Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper p…
- Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper p…
- Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper p…
- Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured…
- Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-103…
- Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387…
- Ibuprofen active pharmaceutical ingredient packaged in varying grams or kg in bags or d…
- Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and…
- Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 2…
- Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle,…
- CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG:…
- IBUPROFEN, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC
- IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only,…
Showing the 65 most recent recalls of ibuprofen products. 68 FDA reports mention ibuprofen 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 ibuprofen recalls
Is there an ibuprofen recall right now?
There are no new FDA ibuprofen recall reports in the last 90 days as of October 7, 2026. The most recent was “Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Man…” from STRIDES PHARMA INC (Class II), reported Mar 25, 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 ibuprofen product?
If you have a recalled ibuprofen 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 ibuprofen 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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