Monarch PCM recalls 4% hydroquinone skin bleaching cream due to subpotency in active and preservative assays. This may affect product effectiveness. No remedy specified in official notice.
“Monarch PCM Hydroquinone Cream Recall: Subpotency Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35870-monarch-pcm-hydroquinone-cream-recall-subpotency-risk. Based on FDA recall #D-0818-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0818-2021%22&limit=1).
Monarch PCM, LLC voluntarily recalled Hydroquinone, USP, 4% Skin Bleaching Cream due to subpotency issues, according to the FDA. The Food and Drug Administration announced the Class III recall on September 1, 2021.
The recall addresses subpotency, specifically where one product failed the active ingredient assay and another failed the preservative assay. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Monarch PCM, LLC has issued three other recalls since September 2, 2021, including a Phenobarbital Elixir recall on April 14, 2022, for exceeding USP alcohol standards and a Hydroquinone Cream recall on September 23, 2021, for not meeting USP specifications. Other recent recalls of similar products include CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (March 18, 2026), CoValence Laboratories Skin Rehab Gel Recall (March 18, 2026), and CoValence Laboratories Essential Calming Skin Gel Hydrocortisone 1% Recall (March 18, 2026).
How to tell if you have this one
Check for the 1 oz (28.35g) tube labeled 'Hydroquinone, USP, 4% Skin Bleaching Cream', with NDC 69367-174-01. The product was manufactured for Westminster Pharmaceuticals, LLC in Nashville, TN.
Brand
Monarch PCM
Product
Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
OH, TN
Recall number
Product, codes & lots
Quantity
NDC
D-0817-2021
Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747; Lots: a) 21FP1737 Exp 05/2023; b) 21FP1738 Exp 05/2023
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0818-2021 (September 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0818-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.