The Recall Desk
ModerateFDA (Drugs)·D-0300-2020·Announced 2019-11-06

Taro Recalls Children's Ibuprofen Oral Suspension Due to Foreign Plastic Particles

Taro Pharmaceuticals is recalling specific lots of Children's Ibuprofen Oral Suspension because they may contain small particles of inert plastic introduced during manufacturing.

What this means for you

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 inert plastic particles, which represents a low-risk contamination or minor defect without reported serious injuries.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 182,986 bottles of Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL). The affected product is distributed nationwide in the U.S.A. and is identified by NDC 51672-2130-8.

The recall was initiated because the medication may contain small particles of an inert plastic material that were introduced during the manufacturing process. The affected lots are E875131667 and E875231667 (Exp 4/20), J871033189 and J871133189 (Exp 9/20), and A972934375 and A973034375 (Exp 12/20).

Consumers should check their medication bottles for these specific lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and contact Taro Pharmaceuticals or their healthcare provider for 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 — OTC Pain Reliever
Hazard
Affected units
182,986

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 (9)

  • Lot #: E875131667
  • E875231667
  • Exp 4/20
  • J871033189
  • J871133189
  • Exp 9/20
  • A972934375
  • A973034375
  • Exp 12/20

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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Same hazard · foreign substance

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