Hydroquinone USP — Class II drug recall D-0855-2021
Terminated recall by Monarch PCM, LLC, reported 2021-10-06, distributed in TN. Finished product specification did not meet USP specifications.
| Recall number | D-0855-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monarch PCM, LLC, Fort Worth, TX, United States |
| Recall initiated | 2021-09-23 |
| Classified | 2021-09-27 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2023-06-23 |
| Distributed | TN |
| Quantity | 11,419 tubes |
| NDC | 69367-0174, 69367-0174-01 |
| Lot numbers | 21FP1743, 21FP1745 |
| Expiration dates | 2023-05 |
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 for recall
Finished product specification did not meet USP specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0855-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.