The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1588-2019·Announced 2019-08-14

Herbal Doctor Remedies Recalls Asthma Balm Due to Manufacturing Deviations

Herbal Doctor Remedies is recalling Asthma Balm 60 gram because it was manufactured outside of current Good Manufacturing Practices controls.

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 the source text cites CGMP deviations without reporting specific illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Herbal Doctor Remedies is recalling Asthma Balm 60 gram. The product was distributed nationwide within the United States and Brazil, as well as on the internet. The recall covers all lots within expiry.

The recall was initiated because the products were manufactured outside of the controls required by current Good Manufacturing Practices (CGMP). This deviation indicates that the manufacturing process did not meet the necessary regulatory standards for quality and safety.

Consumers who have purchased this product should stop using it and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions or a refund.

The recalled product

Product
Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Manufacturer
Herbal Doctor Remedies
Category
Drug — Topical Ointment
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 within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 43 recalled by Herbal Doctor Remedies 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 43 products in this recall →

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