CLASS II Drug recall · Reported 22 Mar 2017 · FDA Enforcement Report
Sulfacetamide 10%/hydrocortisone 1% Cream recalled by Synergy Rx
Synergy Rx is recalling Sulfacetamide 10%/hydrocortisone 1% Cream, distributed nationwide in the US. The recall was initiated on 10 Feb 2017 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-0597-2017
- FDA event ID
- 76472
- Recalling firm
- Synergy Rx, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2017
- FDA classified
- 15 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Feb 2017 | Recall initiated by company | |
| 15 Mar 2017 | Classified by FDA | +33 days |
| 22 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: There are also CGMP Deviations.
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
SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Sulfacetamide 10%/hydrocortisone 1% Cream recalled?
Yes. Synergy Rx recalled Sulfacetamide 10%/hydrocortisone 1% Cream on 10 Feb 2017. The recall is Class II and its status is Terminated. Recall number D-0597-2017.
Why was it recalled?
Lack of Assurance of Sterility: There are also CGMP Deviations.
Which lots are affected?
All Lots
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 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 Synergy Rx
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|---|---|---|---|---|---|
| Drug | CLASS II | Tca Peel Solution in all strengths including recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |
| Drug | CLASS II | Retinoic Acid Solution in all strengths including recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |
| Drug | CLASS II | Adapalene 1%, Benzoyl Peroxide 5% Gel, Adapelene recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |
| Drug | CLASS II | Bicarbonate 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San recalled | Synergy Rx | Sterility | Nationwide |
| Drug | CLASS II | Retinoic Acid all strengths including recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |