CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report

Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone) spray recalled

Valeant Pharmaceuticals North America is recalling Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone) spray, 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

Lot, batch or date codesLot #: 171205E, 171951E, Exp 5/19; 173365K, Exp 10/19

Quantity recalled18,408 bottles

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-0084-2019
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 Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028

Where it was distributed

Product was distributed throughout the United States

Nationwide

Questions about this recall

Is Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone) spray recalled?

Yes. Valeant Pharmaceuticals North America recalled Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone) spray on 24 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-0084-2019.

Why was it recalled?

Which lots are affected?

Lot #: 171205E, 171951E, Exp 5/19; 173365K, Exp 10/19

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 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 Valeant Pharmaceuticals North America

All 25

Reported	Class	Recall	Company	Reason	Where
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Diltiazem HCl CD capsules, 360 mg recalled	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide