Ibuprofen Suspension
FDA Recall NDC 51672-1385
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ibuprofen (NDC 51672-1385). A significant event, classified as Class II, was initiated on Sep 27, 2019 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Sep 27, 2019
Nov 06, 2019
138,886 bottles
Recall Profile & Regulatory Data
Event ID
83887
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Aug 31, 2023
Product Description
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
Batch or Lot Expiration Information
Lot# : K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21
Affected Packages Involved in this Recall
51672-1385-8Product
51672-1385-9Product
Class II Terminated
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Sep 27, 2019
Nov 06, 2019
639,325 bottles
Recall Profile & Regulatory Data
Event ID
83887
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Aug 31, 2023
Product Description
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
Batch or Lot Expiration Information
Lot# : J78402968, J784129698, Exp 9/19; K765129698, K765229698, K765329698, K769329698, K778829698, K778929698, Exp 10/19; A887230568, A887330568, A887430568, Exp 12/19; B865430568, B865530568, B865630568, B869530568, B869630568, Exp 1/20; D866431198, D866531198, D866631198, D866731198, D866831198, D866931198, D872631198, D872731198, D872831198, D872931198, D873031834, Exp 3/20; E875331834, E875431834, E883831834, E883931834, E884031834, E884131834, Exp 4/20; F865131834, Exp 5/20; G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, G882232436, Exp 6/20; H865232436, H865332436, H870832436, Exp 7/20; I885233156, I885333156, I885433156, I885533156, I885633156, I885733164, Exp 8/20; J868533164, J868633164, J868733164, J868833164, J868933164 and J869033164, Exp 9/20; L866434042, L866534043, L866634044, L866734045, L866834046, L866934422, Exp 11/20; A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, A979834428, Exp 12/20; B974034749, B974134750, B974234751, B974334752, B974434753, Exp 1/21
Affected Packages Involved in this Recall
51672-1385-8Product
51672-1385-9Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
