The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1435-2022·Announced 2022-08-31

Four Topical Analgesic Products Recalled for Improper Storage Conditions

Four topical analgesic products distributed to Family Dollar stores were recalled due to CGMP violations involving improper storage temperature conditions. No illnesses or injuries have been reported.

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: FDA Class II recall with no reported illnesses or injuries. The recall involves CGMP deviations related to improper storage conditions on topical analgesic products, constituting a precautionary recall for a lower-risk product category with theoretical hazards of product degradation and reduced efficacy.

Plain-English summary

Family Dollar Stores, LLC recalled four topical analgesic products—Arthritis Hot Creme (3 oz, SKU 901452), Icy Hot Patch (1 ct, SKU 911030), Icy Hot Muscle Rub (1.25 oz, SKU 920205), and Icy Hot No Mess (1.5 oz, SKU 998751)—distributed to specific Family Dollar store locations between April 30, 2022 and June 10, 2022. The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations involving improper storage temperature conditions.

Products stored outside appropriate temperature ranges may experience degradation and reduced effectiveness. No illnesses or injuries have been reported in connection with this recall.

Consumers who have purchased affected products should discontinue use. Those with questions about affected SKUs may contact their local retailer.

The recalled product

Product
ARTHRITIS HOT CREME 3 OZ SKU 901452 ICY HOT PATCH 1 CT SKU 911030 ICY HOT MUSCLE RUB 1.25 OZ SKU 920205 ICY HOT NO MESS 1.5 OZ SKU 998751 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug — Topical Analgesic
Hazard

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 (4)

  • SKUs: 901452
  • 911030
  • 920205
  • 998751

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 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.

See all 100 products in this recall →

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