The Recall Desk

Manufacturer

Tolmar, Inc.

4 recalls in our database name Tolmar, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2023-10-04

Of the 4 recalls from Tolmar, Inc. 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.

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.

1–4 of 4

  • ModerateFDA (Drugs)·D-1178-2023·2023-10-04

    Prescription Drug Recall: Eligard Leuprolide Contains Higher Than Expected Levels

    Tolmar, Inc. is recalling Eligard (leuprolide acetate) 7.5 mg monthly injectable suspension nationwide because the constituted product contains higher than expected levels of the active ingredient. The affected lot is 13635A1 with expiration date July 31, 2024.

    Product
    ELIGARD — ELIGARD (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1300-2022·2022-08-10

    Naftifine Hydrochloride Gel recalled for failed impurity specifications

    Tolmar Inc. recalls Naftifine Hydrochloride Gel 1% due to out-of-specification impurity test results. The recalled tubes may contain unidentified impurities that exceed acceptable limits.

    Product
    Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmace
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0282-2022·2021-12-22

    Clindamycin and Benzoyl Peroxide Gel Recalled for Superpotent Formulation

    TOLMAR, Inc. is recalling Clindamycin and Benzoyl Peroxide Gel, 1%/5%, nationwide due to a superpotent (higher-than-intended active ingredient) formulation. The voluntary recall affects three specific lots.

    Product
    Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-66402-001·2013-10-30

    Tolmar Recalls Subpotent Ketoconazole Shampoo Nationwide

    Tolmar Inc. is voluntarily recalling 391,055 bottles of 2% Ketoconazole Shampoo nationwide because the product was found to be subpotent.

    Product
    Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
    Category
    Drug
    Distribution
    Distributed nationwide