The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0299-2020·Announced 2019-11-06

Taro Recalls Ibuprofen Oral Suspension Due to Foreign Plastic Particles

Taro Pharmaceuticals is recalling 639,325 bottles of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves an inert foreign substance (plastic particles) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 639,325 bottles of Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint (473 mL), NDC 51672-1385-9. The recall was initiated because the product may contain small particles of an inert plastic material that were introduced during the manufacturing process.

The affected product is distributed nationwide in the U.S.A. The specific lot numbers and expiration dates involved in this recall are listed in the structured product information provided. The product is a prescription-only medication manufactured by Taro Pharmaceuticals Inc. in Brampton, Ontario, Canada, and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, NY.

Consumers and healthcare providers should stop using the affected lots of Ibuprofen Oral Suspension USP and contact their pharmacist or Taro Pharmaceuticals for further instructions on how to return the product or obtain a replacement.

The recalled product

Product
IBUPROFEN (IBUPROFEN)
Brand
IBUPROFEN
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
639,325

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Taro Pharmaceuticals U.S.A., Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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