Hydroquinone 4% Skin Bleaching Cream Recalled for Specification Failure
Monarch PCM, LLC is recalling Hydroquinone USP 4% Skin Bleaching Cream because the finished product did not meet USP (United States Pharmacopeia) specifications. The recall affects 11,419 tubes distributed in Tennessee.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with a manufacturing specification failure. The source text does not report any illnesses, injuries, or deaths, and the hazard is a quality-control issue rather than direct contamination or high-risk pathogen. Per the rubric, Class II recalls without reported illness typically score 2 (Moderate).
Plain-English summary
Monarch PCM, LLC is recalling Hydroquinone USP 4% Skin Bleaching Cream (NDC 69367-174-01) manufactured for Westminster Pharmaceuticals, LLC. The finished product failed to meet United States Pharmacopeia (USP) specifications.
The recalled product consists of 11,419 tubes in 1 oz (28.35g) sizes from lot numbers 21FP1743 and 21FP1745 with an expiration date of May 2023. Distribution was limited to Tennessee.
Consumers who have this product should discontinue use and consult their healthcare provider or pharmacist regarding appropriate next steps. Patients should not stop taking prescribed medications without medical guidance. Healthcare providers and patients with questions can contact their pharmacy or the manufacturer.
The recalled product
- Product
- HYDROQUINONE (HYDROQUINONE)
- Brand
- HYDROQUINONE
- Manufacturer
- Monarch PCM, LLC
- Affected units
- 11,419
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 21FP1743
- 21FP1745 Exp. 05/2023
Distribution
Distributed in 1 state:
Related recalls
Same brand · HYDROQUINONE
- ModerateHydroquinone Skin Bleaching Cream Recalled for Subpotency Issues
FDA (Drugs) · 2021-09-29
Same manufacturer · Monarch PCM, LLC
See all →- ModeratePhenobarbital Elixir recalled for exceeding alcohol content specification
FDA (Drugs) · 2022-05-25
- ModerateFerretts IPS Iron Liquid Dietary Supplement Stability Recall
FDA (Food) · 2021-10-06
- ModerateSodium Sulfacetamide Wash Recalled for Subpotency Issues
FDA (Drugs) · 2021-09-29
Same hazard · quality specification failure
See all →- ModerateDuPont Recalls Avicel PH-101 Microcrystalline Cellulose for Out-of-Specification Conductivity
FDA (Drugs) · 2023-05-03
- ModerateMoxifloxacin Ophthalmic Solution Recall for Failed Impurities Specifications
FDA (Drugs) · 2022-02-23
Similar recalls
- ModerateHydroquinone Skin Bleaching Cream Recalled for Subpotency Issues
FDA (Drugs) · 2021-09-29
- ModerateUS Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateCrown Laboratories Recalls Nystatin Cream for Subpotent Drug Levels
FDA (Drugs) · 2020-07-01
- SevereSynergy Rx Recalls Quad Bleaching Cream Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- ModerateCrown Laboratories Recalls Subpotent Nystatin Cream Tubes
FDA (Drugs) · 2020-07-01
- SevereSynergy Rx Recalls Hydroquinone Cream Due to Sterility Assurance Issues
FDA (Drugs) · 2017-03-22