The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0115-2019·Announced 2018-11-07

Sprayology Recalls TravelEase Homeopathic Oral Spray Due to CGMP Deviations

Sprayology is recalling 1,307 bottles of TravelEase Homeopathic Oral Spray nationwide due to manufacturing deviations that could result in 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 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: The recall is classified as FDA Class II and involves a theoretical risk of microbial contamination without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Sprayology is voluntarily recalling 1,307 bottles of TravelEase Homeopathic Oral Spray, 1.38 fl. oz (41ml). The product is identified by NDC 61096-0007-1 and Tester NDC 61096-1007-1. The recall includes all lots within their expiration dates.

The recall was initiated because the product was manufactured by a contract manufacturer under conditions that deviated from Current Good Manufacturing Practices (CGMP). These deviations could result in possible microbial contamination of the product.

The affected product was distributed nationwide in the USA. Consumers who possess this product should stop using it and contact Sprayology for further instructions.

The recalled product

Product
TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1
Manufacturer
Sprayology
Category
Drug — Homeopathic
Hazard
Affected units
1,307

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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