CLASS II Drug recall · Reported 20 Apr 2022 · FDA Enforcement Report

Clobetasol Propionate Lotion 0.05%, Generic for Temovate recalled

Preferred Pharmaceuticals is recalling Clobetasol Propionate Lotion 0.05%, Generic for Temovate, distributed in Illinois. The recall was initiated on 23 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: A0721O, A1421Y, A2121G, A2821D, B0421H, B0421I, B0521U, B1121G, B1921C, C0421B, C1821N, L0120F, L2320O, L3020T, Exp.: 4/30/2022; B2521A, C1121S, C2521U, D0121S, D0921B, D1421B, D2921C, E0721A, Exp.: 10/31/2022; D2221A, Exp.: 12/31/2022

Quantity recalled1568 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-0768-2022
FDA event ID: 89924
Recalling firm: Preferred Pharmaceuticals, Anaheim, CA
Classification: Class II
Status: Terminated
Recall initiated: 23 Mar 2022
FDA classified: 14 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

23 Mar 2022	Recall initiated by company
14 Apr 2022	Classified by FDA	+22 days
20 Apr 2022	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

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

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

Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01

Where it was distributed

Illinois

Questions about this recall

Why was it recalled?

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

Which lots are affected?

Lot #: A0721O, A1421Y, A2121G, A2821D, B0421H, B0421I, B0521U, B1121G, B1921C, C0421B, C1821N, L0120F, L2320O, L3020T, Exp.: 4/30/2022; B2521A, C1121S, C2521U, D0121S, D0921B, D1421B, D2921C, E0721A, Exp.: 10/31/2022; D2221A, Exp.: 12/31/2022

Where was it sold?

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.

More recalls from Preferred Pharmaceuticals

All 55

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears	Preferred Pharmaceuticals	Sterility	Nationwide
24 Dec 2025Drug	CLASS II	Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled	Preferred Pharmaceuticals	Packaging Defects	CA
7 May 2025Drug	CLASS II	Clindamycin Hydrochloride Capsules, USP, 300mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
4 Sep 2024Drug	CLASS II	Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled	Preferred Pharmaceuticals	Potency & Assay	CA, NV
29 May 2024Drug	CLASS II	Duloxetine Delayed-Release Cap USP 30mg recalled	Preferred Pharmaceuticals	Nitrosamine Impurity	5 states

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
30 Mar 2022Drug	CLASS II	Clobetasol Propionate Lotion recalled by Teligent Pharma	Teligent Pharma	Potency & Assay	Nationwide