CLASS II Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report

Children's Ibuprofen Oral Suspension USP, 100 mg recalled

Taro Pharmaceuticals U is recalling Children's Ibuprofen Oral Suspension USP, 100 mg per, Berry Flavor, Dye-Free, Alcohol Free, distributed nationwide in the US. The recall was initiated on 27 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: J871033187, Exp 9/20

NDC51672-2130

Quantity recalled5,190 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0301-2020
FDA event ID: 83887
Recalling firm: Taro Pharmaceuticals U, Hawthorne, NY
Brand: Ibuprofen
Manufacturer: Sun Pharmaceutical Industries, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 27 Sep 2019
FDA classified: 5 Nov 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Pain Medication

Timeline

27 Sep 2019	Recall initiated by company
5 Nov 2019	Classified by FDA	+39 days
6 Nov 2019	Published in enforcement report	+1 day

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Product as listed by the FDA

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 was distributed

U.S.A. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Which lots are affected?

Lot #: J871033187, Exp 9/20

Where was it sold?

U.S.A. Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 83887

This product is part of a recall event; the main page for the event is Ibuprofen Oral Suspension USP, 100 mg recalled.

Reported	Class	Recall	Company	Reason	Where
6 Nov 2019	CLASS II	Ibuprofen Oral Suspension USP, 100 mg recalledIbuprofen	Taro Pharmaceuticals U	Particulate Matter	Nationwide
6 Nov 2019	CLASS II	Ibuprofen Oral Suspension USP, 100 mg recalledIbuprofen	Taro Pharmaceuticals U	Particulate Matter	Nationwide
6 Nov 2019	CLASS II	Children's Ibuprofen Oral Suspension USP, 100 mg recalled	Taro Pharmaceuticals U	Particulate Matter	Nationwide
6 Nov 2019	CLASS II	Children's Ibuprofen Oral Suspension USP, 100 mg recalledIbuprofen	Taro Pharmaceuticals U	Particulate Matter	Nationwide

More recalls from Taro Pharmaceuticals U

All 36

Reported	Class	Recall	Company	Reason	Where
21 Aug 2024Drug	CLASS III	Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled	Taro Pharmaceuticals U	Potency & Assay	NY
6 Apr 2022Drug	CLASS III	Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate	Taro Pharmaceuticals U	Potency & Assay	NY
19 Jan 2022Drug	CLASS I	Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate	Taro Pharmaceuticals U	Sterility	Nationwide
10 Feb 2021Drug	CLASS II	Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride	Taro Pharmaceuticals U	Manufacturing (CGMP) Deviations	Nationwide
23 Dec 2020Drug	CLASS II	H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB	Taro Pharmaceuticals U	Potency & Assay	Nationwide

Other Ibuprofen recalls

All 41

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen	Strides Pharma	Particulate Matter	Nationwide
27 Nov 2024Drug	CLASS III	IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Other	Nationwide
13 Nov 2024Drug	CLASS II	Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled	Direct Rx	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide