The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0694-2021·Announced 2021-07-21

Prairie Wolf Distillery Hand Sanitizer Recalled for Misleading Beverage-Like Packaging

Prairie Wolf Distillery Alcohol Antiseptic 80% hand sanitizer is being recalled because the bottles resemble beverage containers, creating a risk of accidental ingestion. The recall affects all lots of both the 500 mL and 591 mL sizes distributed nationwide.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of a drug product. The hazard—accidental ingestion of a topical antiseptic due to misleading packaging—presents a direct risk of serious injury or harm, satisfying the Class I classification criterion for a severity score of at least 4.

Plain-English summary

Prairie Wolf Distillery Alcohol Antiseptic 80%, a topical solution hand sanitizer, is being recalled by the manufacturer and the FDA. The product is packaged in bottles in two sizes: 16.9 oz (500 mL, UPC 860003318997, NDC 73891-100-14) and 20 oz (591 mL, UPC 860003659847, NDC 73891-100-15).

The recall is issued because the bottles resemble beverage containers, which could lead consumers to accidentally ingest the product. This is particularly hazardous because the hand sanitizer is not intended for internal use.

All lots of both package sizes are affected. The product was distributed nationwide in the United States and is manufactured by Prairie Wolf Spirits in Guthrie, Oklahoma.

Consumers who have purchased this hand sanitizer should stop using it immediately and contact Prairie Wolf Spirits or the FDA if they have any questions or concerns.

The recalled product

Product
Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, Oklahoma
Manufacturer
Prairie Wolf Spirits
Category
Drug — Topical Antiseptic / Hand Sanitizer
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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

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