The Recall Desk
ModerateFDA (Drugs)·D-0565-2023·Announced 2023-05-10

Advil Dual Action Pain Reliever Recalled for Storage Temperature Deviation

Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.

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: This is an FDA Class II recall of a drug product stored outside labeled temperature requirements. No evidence of harm is presented in the source. The hazard is a manufacturing compliance deviation with potential but undemonstrated impact on product efficacy or safety.

Plain-English summary

Family Dollar Stores, Llc. is recalling Advil Dual Action with Acetaminophen pain reliever tablets in 36-caplet bottles. The product contains 250 mg of Acetaminophen and 125 mg of Ibuprofen per dose. The recall was issued because the product was stored outside the temperature conditions specified on the product label, which is a violation of Current Good Manufacturing Practice (CGMP) standards.

The affected product, identified by SKU 0902867, was distributed nationwide. The recall covers product stored and distributed from July 28, 2022 through March 31, 2023.

Consumers who have purchased this product should check the SKU number to determine if their bottles are affected. If you have this product, contact Family Dollar Stores for further instructions on how to return or dispose of it.

The recalled product

Product
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Manufacturer
Family Dollar Stores, Llc.
Category
Drug — Pain Relief
Hazard
  • improper-storage
  • manufacturing-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)

  • SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category