The Recall Desk

Manufacturer

Monarch PCM, LLC

5 recalls in our database name Monarch PCM, LLC as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2022-05-25

Of the 5 recalls from Monarch PCM, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • ModerateFDA (Drugs)·D-0878-2022·2022-05-25

    Phenobarbital Elixir recalled for exceeding alcohol content specification

    Monarch PCM, LLC is recalling Phenobarbital Elixir USP 20 mg/5 mL because the product exceeds the USP specification for alcohol content. Approximately 15,730 bottles distributed in Tennessee are affected.

    Product
    Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0855-2021·2021-10-06

    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.

    Product
    HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1020-2021·2021-10-06

    Ferretts IPS Iron Liquid Dietary Supplement Stability Recall

    Monarch PCM, LLC is recalling Ferretts IPS Iron Liquid Dietary Supplement because stability testing shows the product degraded to 81% potency over a 3-month period, falling below specification limits.

    Product
    Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0817-2021·2021-09-29

    Sodium Sulfacetamide Wash Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Sodium Sulfacetamide 10% Wash due to subpotency, meaning some bottles contain insufficient active ingredient or preservative levels.

    Product
    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
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0818-2021·2021-09-29

    Hydroquinone Skin Bleaching Cream Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.

    Product
    HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
    Category
    Drug
    Distribution
    2 states