The Recall Desk
ModerateFDA (Drugs)·D-1492-2019·Announced 2019-07-31

Pharma-Natural Recalls Oliver's Harvest CBD+Capsaicin Cream for CGMP Violations

Pharma-Natural Inc. is recalling 998 bottles of Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief Cream due to current good manufacturing practice violations.

What this means for you

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 due to CGMP deviations (lack of validation and stability studies) without reported illnesses or injuries, fitting the criteria for moderate severity involving potential quality issues.

Plain-English summary

Pharma-Natural Inc. is recalling 998 bottles of Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump. The product is distributed by Coast to Coast Natural, Inc., in Wellington, FL, and carries the NDC 63788-120-04.

The recall was initiated because the products were manufactured with a lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice (CGMP) violations. The agency has classified this recall as Class II.

The affected units were distributed to consignees in Florida and Texas, who may have further distributed the product nationwide in the USA and Puerto Rico. All lots remaining within their expiry dates are included in this recall. Consumers should stop using the product and contact the distributor or manufacturer for instructions on return or disposal.

The recalled product

Product
Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
998

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 remaining within expiry.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 16 recalled by Pharma-Natural Inc. 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 16 products in this recall →

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