Monarch PCM Hydroquinone Recall: FDA Class II

Why it was recalled

Finished product specification did not meet USP specifications.

Product description

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

Lot numbers, UPCs & expiration codes

Lots: 21FP1743, 21FP1745 Exp. 05/2023

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0855-2021
Classification: Class II
Status: Terminated
Recall initiated: Sep 23, 2021
FDA report date: Oct 6, 2021
Quantity: 11,419 tubes
Recall type: Voluntary: Firm initiated
Recalling firm: Monarch PCM, LLC

Original FDA data

Every field from FDA enforcement report D-0855-2021, exactly as published.

Show all FDA fields

City: Fort Worth
State: TX
Status: Terminated
Country: United States
Event ID: 88755
Address: 7333 Jack Newell Blvd N Ste 100
Code information: Lots: 21FP1743, 21FP1745 Exp. 05/2023
Postal code: 76118-7151
Report date: Oct 6, 2021
Product type: Drugs
Recall number: D-0855-2021
Classification: Class II
Recalling firm: Monarch PCM, LLC
Product quantity: 11,419 tubes
Termination date: Jun 23, 2023
Reason for recall: Finished product specification did not meet USP specifications.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: TN
Recall initiation date: Sep 23, 2021
Initial firm notification: Letter
Center classification date: Sep 27, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0855-2021, published Oct 6, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Monarch PCM Hydroquinone Recall

Summary