Advil Liqui-Gels 200 mg ibuprofen capsules recalled for improper storage
Family Dollar Stores is recalling Advil Liqui-Gels 200 mg ibuprofen capsules (SKUs 0999841 and 0916071) distributed nationwide due to storage outside labeled temperature requirements.
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 3/5 (High).
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 for a Current Good Manufacturing Practice deviation involving storage temperature violations. Improper storage of pharmaceutical products presents a risk of harm to medication safety and efficacy.
Plain-English summary
Family Dollar Stores, Llc. is recalling Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg in both 20-count and 40-count bottles. The product was distributed nationwide between July 28, 2022 and March 31, 2023. Affected SKU numbers are 0999841 (20-count) and 0916071 (40-count).
The recall was initiated because the product was stored outside its labeled storage temperature requirements, which constitutes a violation of Current Good Manufacturing Practice (CGMP) standards. The U.S. Food and Drug Administration has classified this as a Class II recall.
Consumers should not use any affected product and should contact Family Dollar Stores for replacement or refund information.
The recalled product
- Product
- Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug
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)
- SKUs a) 0999841
- b) 0916071 stored and distributed from DCs 07/28/2022 through 03/31/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Family Dollar Stores, Llc. 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.
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