The Recall Desk
ModerateFDA (Drugs)·D-0301-2020·Announced 2019-11-06

Taro Recalls Children's Ibuprofen Suspension Due to Plastic Particles

Taro Pharmaceuticals is recalling 5,190 bottles of Children's Ibuprofen Oral Suspension because small particles of inert plastic may be present.

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 the presence of an inert foreign substance (plastic particles) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 5,190 bottles of Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz. (240 mL). The product is identified by NDC 51672-2130-1, Lot # J871033187, and an expiration date of 9/20.

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 product was distributed nationwide in the United States.

Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact Taro Pharmaceuticals or their healthcare provider for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
IBUPROFEN (IBUPROFEN)
Brand
IBUPROFEN
Affected units
5,190

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 (2)

  • Lot #: J871033187
  • Exp 9/20

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 →