The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0298-2020·Announced 2019-11-06

Taro Recalls Ibuprofen Oral Suspension Due to Foreign Plastic Particles

Taro Pharmaceuticals is recalling specific lots 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 inert plastic particles, which are low-risk contaminants without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 138,886 bottles of Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz. (118 mL). 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.

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 is identified by NDC 51672-1385-8 and includes the following lot numbers and expiration dates: K779030125 (Exp 10/19), D873031376 (Exp 3/20), J871233188 (Exp 9/20), L866934047 (Exp 11/20), A973134376 (Exp 12/20), and D967635229 (Exp 3/21).

The affected product was distributed nationwide in the U.S.A. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.

The recalled product

Product
IBUPROFEN (IBUPROFEN)
Brand
IBUPROFEN
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — Oral Suspension
Hazard
Affected units
138,886

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 (12)

  • Lot #: K779030125
  • Exp 10/19
  • D873031376
  • Exp 3/20
  • J871233188
  • Exp 9/20
  • L866934047
  • Exp 11/20
  • A973134376
  • 12/20
  • D967635229
  • Exp 3/21

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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