RecallRadar

FDA Drug recall D-0689-2022

Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15

On 2022-03-30 the FDA classified a Class II recall of Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15 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-0689-2022
ClassificationClass II
Statusterminated
Initiated2022-03-15
Published2022-03-30
Last updated2026-09-13 11:52 UTC
CompanyTeligent Pharma
DistributionUS

Product

Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, 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) 15280, Exp. 2/28/2022; 16539, Exp. 3/31/2023; 16907, Exp. 5/31/2023; b) 15381, Exp. 3/31/2022; 15382, 15501,…Batch: a) 15280, Exp. 2/28/2022; 16539, Exp. 3/31/2023; 16907, Exp. 5/31/2023; b) 15381, Exp. 3/31/2022; 15382, 15501, 15523, Exp. 4/30/2022; 15812, Exp. 7/31/2022; 15972, 16034, 16037, Exp. 9/30/2022; 16105, 16143, Exp. 10/31/2022; 16539, 16746, 16747, Exp. 3/31/2023; 16906, Exp. 5/31/2023; 16962, 17041, Exp. 6/30/2023; 17110, Exp. 7/31/2023

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-0689-2022%22

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