Reported Nov 6, 2019 · Terminated

Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc.,…

Taro Pharmaceuticals U.S.A., Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174

Is this the product you have?

  • Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only
  • Manufactured byTaro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
  • Distributed byTaro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9
Lot codes and dates

14 of 14 products

Products covered by this recall
#Product as published
1J78402968, J784129698, Exp 9/19
2K765129698, K765229698, K765329698, K769329698, K778829698, K778929698, Exp 10/19
3A887230568, A887330568, A887430568, Exp 12/19
4B865430568, B865530568, B865630568, B869530568, B869630568, Exp 1/20
5D866431198, D866531198, D866631198, D866731198, D866831198, D866931198, D872631198, D872731198, D872831198, D872931198, D873031834, Exp 3/20
6E875331834, E875431834, E883831834, E883931834, E884031834, E884131834, Exp 4/20
7F865131834, Exp 5/20
8G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, G882232436, Exp 6/20
9H865232436, H865332436, H870832436, Exp 7/20
10I885233156, I885333156, I885433156, I885533156, I885633156, I885733164, Exp 8/20
11J868533164, J868633164, J868733164, J868833164, J868933164 and J869033164, Exp 9/20
12L866434042, L866534043, L866634044, L866734045, L866834046, L866934422, Exp 11/20
13A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, A979834428, Exp 12/20
14B974034749, B974134750, B974234751, B974334752, B974434753, Exp 1/21
Amount recalled
639,325 bottles

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 31, 2023 · Data as of Sep 19, 5:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.