CLASS III Drug recall · Reported 12 Jul 2017 · FDA Enforcement Report

G & W Clobetasol Propionate Ointment recalled by G & W Laboratories

G & W Laboratories is recalling G & W Clobetasol Propionate Ointment 0.05%, distributed nationwide in the US. The recall was initiated on 2 Jun 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: a) 1001090, Exp 8/ 17; 1002881, Exp 2/18; b) 1001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18; c) 1001155, Exp 9/17; 1004572, Exp 7/18; d) 1001158, Exp 9/17; 1001159, Exp 10/17; 1002884, Exp 4/18

NDC0713-0656

UPC0307130656313

Quantity recalled145284 tubes

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-0945-2017
FDA event ID: 77401
Recalling firm: G & W Laboratories, South Plainfield, NJ
Brand: Clobetasol Propionate
Manufacturer: Cosette Pharmaceuticals, Inc.
Classification: Class III
Status: Terminated
Recall initiated: 2 Jun 2017
FDA classified: 6 Jul 2017
Reported: 12 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

2 Jun 2017	Recall initiated by company
6 Jul 2017	Classified by FDA	+34 days
12 Jul 2017	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

Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.

Which lots are affected?

Lot #: a) 1001090, Exp 8/ 17; 1002881, Exp 2/18; b) 1001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18; c) 1001155, Exp 9/17; 1004572, Exp 7/18; d) 1001158, Exp 9/17; 1001159, Exp 10/17; 1002884, Exp 4/18

Where was it sold?

Nationwide

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.

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Other Clobetasol Propionate recalls

All 21

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate	Lupin Pharmaceuticals	Other	Nationwide
7 Jun 2023Drug	CLASS II	Clobetasol Propionate Ointment, USP, 0.05% tubes recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Clobetasol Propionate Cream recalled by Akorn	Akorn	Potency & Assay	Nationwide
1 Feb 2023Drug	CLASS III	Clobetasol propionate Cream USP, 0.05% tube recalledClobetasol Propionate	Lupin Pharmaceuticals	Potency & Assay	Nationwide
20 Apr 2022Drug	CLASS II	Clobetasol Propionate Lotion 0.05%, Generic for Temovate recalled	Preferred Pharmaceuticals	Potency & Assay	IL