The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0302-2020·Announced 2019-11-06

Taro Recalls Children's Ibuprofen Suspension Due to Plastic Particles

Taro Pharmaceuticals is recalling 5,280 bottles of Children's Ibuprofen Oral Suspension due to the presence of small inert plastic particles.

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, but the hazard involves inert plastic particles with no reported injuries or illnesses, fitting the criteria for a moderate risk.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 5,280 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 product is distributed by Winco Foods, LLC, and carries the NDC 67091-321-04. The specific lot affected is A972834374, with an expiration date of 12/20.

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
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — Oral Suspension
Hazard
Affected units
5,280

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 #: A972834374
  • 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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