Monarch PCM Hydroquinone Cream Recall: Product Doesn't Meet USP Standards
Monarch PCM recalls 4% hydroquinone skin bleaching cream (Rx only) due to failing USP specifications. Affected units were manufactured for Westminster Pharmaceuticals in Nashville, TN. No remedy specified in recall notice.
Recall notice
Finished product specification did not meet USP specifications.
Contact the company
What happened, in plain English
Monarch PCM is recalling 4% hydroquinone skin bleaching cream (Rx only) because it didn't meet USP quality standards. This means the product may not be safe or effective as intended, but the recall doesn't include a specific fix or return process. Read more at govinfonow.com/recall/35840-monarch-pcm-hydroquinone-cream-recall-product-doesn-t-meet-usp.
Source Summary by GovInfoNow · govinfonow.com/recall/35840-monarch-pcm-hydroquinone-cream-recall-product-doesn-t-meet-usp · Updated August 18, 2026 · FDA enforcement record: FDA #D-0855-2021
Cite this page
“Monarch PCM Hydroquinone Cream Recall: Product Doesn't Meet USP Standards.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35840-monarch-pcm-hydroquinone-cream-recall-product-doesn-t-meet-usp. Based on FDA recall #D-0855-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0855-2021%22&limit=1).
Why it’s dangerous
The product failed to meet USP specifications, which are strict quality standards for medications. This could mean the cream isn't safe or effective for skin bleaching as intended, but the recall doesn't specify what harm it could cause.
Who’s affected
People who have the 4% hydroquinone skin bleaching cream (Rx only) with the specific lot numbers and expiration date listed in the recall notice. Those who use prescription skin lightening products are most at risk if they have this product.
How to tell if you have this one
Check for the product name 'Hydroquinone USP, 4% Skin Bleaching Cream', Rx only, 1 oz (28.35g) with lot numbers 21FP1743 or 21FP1745 and expiration date 05/2023.
- Brand
Monarch PCM- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers 21FP1743 or 21FP1745 and expiration date 05/2023 on the product label.
Where it went and when
Where it was distributed
Distributed in Tennessee.
FDA distribution: “TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0855-2021 (September 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0855-2021 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.