CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone) recalled
Valeant Pharmaceuticals North America is recalling Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), distributed nationwide in the US. The recall was initiated on 24 Aug 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-0086-2019
- FDA event ID
- 81004
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2018
- FDA classified
- 22 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 24 Aug 2018 | Recall initiated by company | |
| 22 Oct 2018 | Classified by FDA | +59 days |
| 31 Oct 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: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
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
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
Where it was distributed
Product was distributed throughout the United States
Questions about this recall
Why was it recalled?
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Which lots are affected?
Lot #: 172185F, Exp 6/19
Where was it sold?
Product was distributed throughout 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.
Other products in this recall event
2 other products · FDA event 81004This product is part of a recall event; the main page for the event is Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone) spray recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone) spray recalled | Valeant Pharmaceuticals North America | Sterility | Nationwide | |
| CLASS II | Cortaid Maximum Strength Cream (1% hydrocortisone) tube recalled | Valeant Pharmaceuticals North America | Sterility | Nationwide |
More recalls from Valeant Pharmaceuticals North America
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl CD capsules, 360 mg recalled | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |