The Recall Desk

Hazard

Impurity Specification Failure recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2022-01-12

Of the 6 impurity specification failure recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all impurity specification failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–6 of 6

  • ModerateFDA (Drugs)·D-0333-2022·2022-01-12

    Berkley Jensen Fexofenadine Tablets Recalled for Impurity Specification Failure

    Perrigo Company PLC is recalling Berkley Jensen Allergy Relief 180 mg fexofenadine tablets due to an impurity specification failure detected during stability testing. The recall affects 7,670 containers distributed nationwide.

    Product
    berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0350-2022·2022-01-12

    TopCare Allergy Relief Fexofenadine tablets recalled for impurity specifications

    Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.

    Product
    TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0344-2022·2022-01-12

    Allergyrelief Fexofenadine Tablets Recalled for Impurity Specification Failure

    Perrigo Company is recalling allergyrelief Fexofenadine Hydrochloride 24HR tablets due to an out-of-specification result for impurity A detected during stability testing.

    Product
    allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lak
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0348-2022·2022-01-12

    Rite Aid Allergy Relief Fexofenadine tablets recalled for impurity

    Perrigo Company PLC is recalling Rite Aid Allergy Relief Fexofenadine Hydrochloride 180mg tablets nationwide due to failed impurity specifications. An out-of-specification result for impurity A was found during stability testing.

    Product
    Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0798-2021·2021-09-22

    Candesartan Cilexetil tablets recalled for impurity specification failure

    Viatris is recalling Candesartan Cilexetil Tablets, USP 16 mg due to failed impurities and degradation specifications. One lot distributed nationwide does not meet required purity standards.

    Product
    CANDESARTAN CILEXETIL — CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-142-2013·2013-02-06

    Femtrace 0.45 mg Tablets Recalled for Moisture Ingress

    Warner Chilcott is recalling 3,155 bottles of Femtrace 0.45 mg tablets due to moisture ingress that failed impurity specifications.

    Product
    Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
    Category
    Drug
    Distribution
    Distributed nationwide