CLASS II Drug recall · Reported 25 Apr 2018 · FDA Enforcement Report
WipeEssentials Wet Wipes (benzalkonium chloride 13%) recalled
Diamond Wipes International is recalling WipeEssentials Wet Wipes (benzalkonium chloride 13%), distributed nationwide in the US. The recall was initiated on 2 Apr 2018 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-0630-2018
- FDA event ID
- 79758
- Recalling firm
- Diamond Wipes International, Chino, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2018
- FDA classified
- 16 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 2 Apr 2018 | Recall initiated by company | |
| 16 Apr 2018 | Classified by FDA | +14 days |
| 25 Apr 2018 | 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: finished products were manufactured with poor quality water.
Product as listed by the FDA
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is WipeEssentials Wet Wipes (benzalkonium chloride 13%) recalled?
Yes. Diamond Wipes International recalled WipeEssentials Wet Wipes (benzalkonium chloride 13%) on 2 Apr 2018. The recall is Class II and its status is Terminated. Recall number D-0630-2018.
Why was it recalled?
CGMP Deviations: finished products were manufactured with poor quality water.
Which lots are affected?
Lot #: 7382A1, 7382B1, 7382A2, 7382B2, 7382A3, 7383A1, 7383B1, 7383A2, 7401A1, 7401B1, 7572A1, 7572B1, 7577B1, 7577A2, 7577B2, EXP 03/18; 7573B1, 7573A2, 7782A1, 7783A1, 7783B1, EXP 04/18; 7984B1, 7984A2, 7984B2, 8043A1, 8043B1, 8403A1, EXP 05/18; 8291A1, 8292B1, 8293A1, 8294B1, EXP 07/18; 8511A1, 8512B1, 8513B1, 8513A2, 8514A1, 8514B1, 8514A2, 8520A1, 8520B1, EXP 08/18; 8818A1, 8821B1, 8821A2, EXP 09/18
Where was it sold?
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 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.
More recalls from Diamond Wipes International
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acure, clarifying acne, glycolic + zinc recalled | Diamond Wipes International | Manufacturing (CGMP) Deviations | Nationwide |