CLASS II Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report
Petroleum jelly (White Petrolatum) recalled by OraLabs, Incorporated
OraLabs is recalling Petroleum jelly (White Petrolatum) USP 100%, distributed nationwide in the US. The recall was initiated on 25 Nov 2019 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-0624-2020
- FDA event ID
- 84437
- Recalling firm
- OraLabs, Parker, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2019
- FDA classified
- 19 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 25 Nov 2019 | Recall initiated by company | |
| 18 Dec 2019 | Published in enforcement report | +23 days |
| 19 Dec 2019 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Product as listed by the FDA
Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011
Where it was distributed
Nationwide within the United States
Stores named: Rite Aid
Questions about this recall
Why was it recalled?
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Which lots are affected?
Lot #: a) 44660922 Exp. 09/22; b) 44771122, Exp. 11/22
Where was it sold?
Nationwide within the United States
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.