RecallRadar

FDA Drug recall D-0855-2021

Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN…

On 2021-10-06 the FDA classified a Class II recall of Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN… by Monarch Pcm, citing finished product specification did not meet USP specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0855-2021
ClassificationClass II
Statusterminated
Initiated2021-09-23
Published2021-10-06
Last updated2026-09-13 11:52 UTC
CompanyMonarch Pcm
DistributionTN

Product

Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01

Reason

Finished product specification did not meet USP specifications.

Identifiers

ndc69367-174-01
code_infoLots: 21FP1743, 21FP1745 Exp. 05/2023

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-0855-2021%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.