CLASS II Drug recall · Reported 2 Dec 2020 · FDA Enforcement Report
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) recalled
AA Products is recalling SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, distributed in Texas. The recall was initiated on 24 Sep 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-0102-2021
- FDA event ID
- 86497
- Recalling firm
- AA Products, Laredo, TX
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 24 Sep 2020
- FDA classified
- 23 Nov 2020
- Reported
- 2 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 24 Sep 2020 | Recall initiated by company | |
| 23 Nov 2020 | Classified by FDA | +60 days |
| 2 Dec 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 manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
Where it was distributed
Texas
Questions about this recall
Why was it recalled?
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Which lots are affected?
EXP MAY/2021
Where was it sold?
Texas
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.