H & H Remedies Recalls Union Salve Due to CGMP Deviations
H & H Remedies, LLC is voluntarily recalling 939 jars of Union (black) salve due to Current Good Manufacturing Practice (CGMP) deviations.
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 is voluntary, with no reported illnesses or injuries in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
H & H Remedies, LLC is voluntarily recalling 939 jars of Union (black) salve. The product is packaged in 1/8 oz, 2 oz, 4 oz, 8 oz, 16 oz, and 32 oz jars. The recall was initiated by the firm on October 21, 2020, and was classified as Class II by the FDA.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected lots are numbered H20-01S through H20-12S. The product was distributed nationwide in the United States. The recall was terminated on May 12, 2024.
Consumers who have the affected product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
- Manufacturer
- H & H Remedies, LLC
- Category
- Drug — Topical Salve
- Hazard
- Affected units
- 939
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)
- Lot #: H20-01S thru H20-12S
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by H & H Remedies, LLC 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.
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