RecallRadar

FDA Drug recall D-0671-2022

Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15

On 2022-03-30 the FDA classified a Class II recall of Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15 by Teligent Pharma, citing cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0671-2022
ClassificationClass II
Statusterminated
Initiated2022-03-15
Published2022-03-30
Last updated2026-09-13 11:52 UTC
CompanyTeligent Pharma
DistributionUS

Product

Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Reason

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Identifiers

code_info
Batch: a) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16130, Exp. 11/30/2022; b) 15117, Exp. 2/28/2022; 16028, Exp. 9…Batch: a) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16130, Exp. 11/30/2022; b) 15117, Exp. 2/28/2022; 16028, Exp. 9/30/2022; 16945, Exp. 5/31/2023; c) 15377, Exp. 3/31/2022; 15927, Exp. 9/30/2022; 16683, Exp. 5/31/2022; d) 15116, Exp. 2/28/2022; 15117, Exp. 2/28/2022; 16130, Exp. 11/30/2022; 16228, Exp. 11/30/2022; 16348, Exp. 1/31/2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0671-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.