The Recall Desk
HighFDA (Drugs)·D-0564-2023·Announced 2023-05-10

Advil Ibuprofen 200mg tablets recalled due to improper storage conditions

Family Dollar Stores is recalling Advil Ibuprofen 200mg caplets stored outside temperature requirements. The recall affects units distributed nationwide from July 2022 through March 2023.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries and a theoretical hazard. Per the rubric: 'If the source text explicitly states no illnesses/injuries reported and the hazard is theoretical, the score is at most 3.'

Plain-English summary

Family Dollar Stores, LLC is recalling Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer in 24-count caplets. The recall applies to product stored and distributed under SKU 0901839 from July 28, 2022 through March 31, 2023, to distribution centers nationwide.

The product was stored outside the labeled temperature requirements, which constitutes a violation of current Good Manufacturing Practice (CGMP) standards. Improper storage conditions may compromise medication quality and efficacy.

Affected consumers should not use recalled product with SKU 0901839. Consumers who have purchased this product are advised to check the SKU number on their packaging.

The recalled product

Product
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Manufacturer
Family Dollar Stores, Llc.
Category
Drug — OTC Pain Reliever
Hazard
  • improper-storage
  • temperature-deviation

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 (1)

  • SKU 0901839 stored and distributed from DCs 07/28/2022 through 03/31/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

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