CLASS II Drug recall · Reported 18 Nov 2020 · FDA Enforcement Report
Union (black) salve recalled by H & H Remedies
H & H Remedies is recalling Union (black) salve, distributed nationwide in the US. The recall was initiated on 21 Oct 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0071-2021
- FDA event ID
- 86712
- Recalling firm
- H & H Remedies, New Philadelphia, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Oct 2020
- FDA classified
- 9 Nov 2020
- Reported
- 18 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 21 Oct 2020 | Recall initiated by company | |
| 9 Nov 2020 | Classified by FDA | +19 days |
| 18 Nov 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
Nationwide in the United States
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: H20-01S thru H20-12S
Where was it sold?
Nationwide in the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 86712This product is part of a recall event; the main page for the event is Vapor Ointment recalled by H & H Remedies.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vapor Ointment recalled by H & H Remedies | H & H Remedies | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | White Liniment recalled by H & H Remedies | H & H Remedies | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from H & H Remedies
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | White Liniment recalled by H & H Remedies | H & H Remedies | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vapor Ointment recalled by H & H Remedies | H & H Remedies | Manufacturing (CGMP) Deviations | Nationwide |