CLASS III Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin recalled
Sigan Industries is recalling Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, distributed in Illinois. The recall was initiated on 7 Jan 2020 and the FDA has classified it as Class III.
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-0782-2020
- FDA event ID
- 84678
- Recalling firm
- Sigan Industries, Brampton
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jan 2020
- FDA classified
- 16 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 Jan 2020 | Recall initiated by company | |
| 16 Jan 2020 | Classified by FDA | +9 days |
| 22 Jan 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of non-sterile product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Where it was distributed
IL
Stores named: CVS
Questions about this recall
Why was it recalled?
Microbial contamination of non-sterile product.
Which lots are affected?
Lot#: 2508-08-337, 2538-08-337, Exp 8/2020
Where was it sold?
IL
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Sigan Industries
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%) recalled | Sigan Industries | Sterility | CA |