The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1384-2022·Announced 2022-08-31

Family Dollar Hydrocortisone and Cortizone Creams Recalled for Storage Deviation

Family Dollar Stores is recalling hydrocortisone cream (1 oz, SKU 910321) and Cortizone 10 Creme (0.5 oz, SKU 910167) distributed April 30 through June 10, 2022, due to improper storage temperature conditions.

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 drug recall due to CGMP deviation involving storage temperature violations. No reported illnesses or injuries, but improper storage of a topical corticosteroid represents a risk-of-harm product where product efficacy or integrity may be compromised.

Plain-English summary

Family Dollar Stores, Llc. is recalling FS Hydrocortisone Cream 1 oz (SKU 910321) and Cortizone 10 Creme 0.5 oz (SKU 910167) distributed to select Family Dollar Stores locations from April 30, 2022 through June 10, 2022. The products are being recalled due to a Current Good Manufacturing Practice (CGMP) deviation involving storage temperature violations.

The products affected by this recall were stored outside appropriate temperature conditions during distribution. Improper storage of topical corticosteroids may affect product quality, safety, or efficacy.

Consumers who purchased these products during the distribution period from affected Family Dollar Stores should contact Family Dollar Stores for information about the recall and disposition of the products.

The recalled product

Product
FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug — Topical corticosteroid
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 (2)

  • SKUs: 910321
  • 910167

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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