CLASS I Drug recall · Reported 23 Sep 2020 · FDA Enforcement Report
Herbacil, Antiseptic Hand Sanitizer, 70% Alcohol recalled
Broncolin is recalling Herbacil, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a), distributed nationwide in the US. The recall was initiated on 27 Jul 2020 and the FDA has classified it as Class I.
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-1578-2020
- FDA event ID
- 86127
- Recalling firm
- Broncolin, Ciudad De Mexico, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Jul 2020
- FDA classified
- 11 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Drug class
- Hand Sanitizer
Timeline
| 27 Jul 2020 | Recall initiated by company | |
| 11 Sep 2020 | Classified by FDA | +46 days |
| 23 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained 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
HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; , Made in Mexico by: Broncolin, S.A. de C.V. Sur 16 No. 353, Col. Agricola Oriental, Iztacalco, C.P. 08500, Cuidad de Mexico, Mexico. Importer/Distributor: INBC TRADING LLC 4404 Merle Drive, Austin, TX 78745.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
Which lots are affected?
Lot# L 201117, Exp 05/2022
Where was it sold?
Distributed Nationwide in the USA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
1 other product · FDA event 86127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Herbacil, Antiseptic Hand Sanitizer, 70% Alcohol recalled | Broncolin | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Broncolin
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Herbacil, Antiseptic Hand Sanitizer, 70% Alcohol recalled | Broncolin | Manufacturing (CGMP) Deviations | Nationwide |