CLASS II ONGOING Drug recall · Reported 22 Nov 2023 · FDA Enforcement Report
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) recalled
Omega & Delta is recalling DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Hecho en Puerto Rico, distributed in Puerto Rico. The recall was initiated on 20 Oct 2023 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-0104-2024
- FDA event ID
- 93159
- Recalling firm
- Omega & Delta, Carolina, PR
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Oct 2023
- FDA classified
- 14 Nov 2023
- Reported
- 22 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Hand Sanitizer
Timeline
| 20 Oct 2023 | Recall initiated by company | |
| 14 Nov 2023 | Classified by FDA | +25 days |
| 22 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Product as listed by the FDA
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
Where it was distributed
Distributed in Puerto Rico only.
Questions about this recall
Why was it recalled?
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Which lots are affected?
Lot #s 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, 0245096.
Where was it sold?
Distributed in Puerto Rico only.
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 93159This product is part of a recall event; the main page for the event is Equate Hand Sanitizer (Ethyl Alcohol 62%) recalled by Omega & Delta Co.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Equate Hand Sanitizer (Ethyl Alcohol 62%) recalled by Omega & Delta Co | Omega & Delta | Other | PR | |
| CLASS II | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) recalled | Omega & Delta | Other | PR |
More recalls from Omega & Delta
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) recalled | Omega & Delta | Other | PR |
| Drug | CLASS II | Equate Hand Sanitizer (Ethyl Alcohol 62%) recalled by Omega & Delta Co | Omega & Delta | Other | PR |