The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0123-2019·Announced 2018-11-07

Sprayology Recalls Body Skin Tonic Due to Potential Microbial Contamination

Sprayology is recalling Body Skin Tonic homeopathic oral spray because it was manufactured under conditions that could result in possible microbial contamination.

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 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: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination risks, even without reported hospitalizations.

Plain-English summary

Sprayology is voluntarily recalling 857 bottles of Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL), NDC 61096-0017-1. The product was distributed nationwide in the USA. The recall was initiated because the product was manufactured by a contract manufacturer under conditions that could result in possible microbial contamination.

The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers who have purchased this product should stop using it and contact Sprayology for further instructions or a refund. The recall covers all lots within the expiry date.

The recalled product

Product
Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1
Manufacturer
Sprayology
Affected units
857

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 within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 22 recalled by Sprayology 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 22 products in this recall →

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