CLASS II Drug recall · Reported 9 Sep 2020 · FDA Enforcement Report
Alcohol Antiseptic Topical Solution, Ethyl Alcohol recalled
Leiper's Fork Distillery is recalling Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, distributed in Tennessee. The recall was initiated on 3 Aug 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-1561-2020
- FDA event ID
- 86182
- Recalling firm
- Leiper's Fork Distillery, Franklin, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2020
- FDA classified
- 3 Sep 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 3 Aug 2020 | Recall initiated by company | |
| 3 Sep 2020 | Classified by FDA | +31 days |
| 9 Sep 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery
Where it was distributed
TN
Questions about this recall
Is Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz recalled?
Yes. Leiper's Fork Distillery recalled Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz on 3 Aug 2020. The recall is Class II and its status is Terminated. Recall number D-1561-2020.
Why was it recalled?
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Which lots are affected?
All Lots
Where was it sold?
TN
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.