The Recall Desk

Manufacturer

Fagron, Inc

22 recalls in our database name Fagron, Inc as the manufacturing or recalling firm.

What the numbers show

Total
22
Critical
0
Severe
3
Most recent
2023-12-27

Of the 22 recalls from Fagron, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (14%) 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.

1–22 of 22

  • HighFDA (Drugs)·D-0157-2024·2023-12-27

    Nystatin Bulk Powder Recall for Incorrect Label Assay Value

    Fagron, Inc. is recalling Nystatin 150 MU bulk powder for prescription compounding because the assay value on the label is incorrect.

    Product
    NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0156-2024·2023-12-27

    Nystatin Bulk Powder Recalled Due to Incorrect Label Strength

    Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.

    Product
    NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0155-2024·2023-12-27

    Nystatin Powder Recall Due to Incorrect Assay Strength on Label

    Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.

    Product
    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0154-2024·2023-12-27

    Nystatin bulk powder recall due to incorrect assay strength label

    Fagron, Inc. is recalling Nystatin 5BU bulk powder for prescription compounding due to an incorrect assay strength label. The product was distributed to pharmacies and repacker/relabelers in the United States and Canada.

    Product
    NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0856-2022·2022-05-18

    SyrSpend SF Suspending Base Recalled for Burkholderia Contamination

    Fagron is recalling SyrSpend SF Suspending Base, Cherry Flavored (NDC 51552-1123-5 and 51552-1123-9) due to contamination with Burkholderia gladioli. This FDA Class I recall affects medication used in compounding.

    Product
    SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0862-2022·2022-05-18

    Fagron recalls Nandrolone Decanoate USP for subpotency in multiple lots

    Fagron, Inc. is recalling 58 containers of Nandrolone Decanoate USP for prescription compounding due to subpotency. The affected lots were distributed nationwide.

    Product
    Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0866-2022·2022-05-18

    FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient

    Fagron, Inc initiated a nationwide recall of Nandrolone Decanoate compounding ingredient due to subpotency. The affected lot may contain below-strength concentrations of the active pharmaceutical ingredient.

    Product
    Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2022·2022-05-18

    FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient from Fagron

    Fagron Inc. initiated a voluntary recall of 68 containers of Nandrolone Decanoate USP in March 2022 after the product was found subpotent, containing less active ingredient than labeled. The recall affects compounding pharmacies nationwide.

    Product
    Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0865-2022·2022-05-18

    Prescription Compounding Drug Nandrolone Decanoate Recalled for Subpotency

    Fagron, Inc. is recalling 2 containers of Nandrolone Decanoate USP used for prescription compounding because the product is subpotent, containing less active ingredient than expected. The recall is nationwide.

    Product
    Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0863-2022·2022-05-18

    FDA recalls Nandrolone Decanoate compounding ingredient for subpotency nationwide

    Fagron, Inc. recalls 53 containers of Nandrolone Decanoate compounding ingredient due to subpotency. The product was distributed nationwide.

    Product
    Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0533-2020·2019-12-11

    Fagron Recalls LETS GEL Kits Due to Microbial Contamination

    Fagron, Inc. is recalling 11,912 kits of LETS GEL Convenience Packs due to microbial contamination of the non-sterile product.

    Product
    LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0547-2018·2018-03-07

    Fagron Recalls SyrSpend SF Suspending Base Due to Microbial Contamination

    Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product was found to be contaminated with yeast and mold.

    Product
    SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0079-2018·2017-11-22

    Fagron Recalls Estriol Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estriol for prescription compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0791-2017·2017-05-31

    Fagron Recalls Estriol Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estriol for prescription compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0792-2017·2017-05-31

    Fagron Recalls Estrone Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estrone for Prescription Compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(8
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0695-2017·2017-05-10

    Fagron Recalls Zinc Oxide Paste Due to Labeling Error

    Fagron, Inc. is recalling Zinc Oxide Paste 25% because of an incorrect strength value in the Drug Facts Panel.

    Product
    Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0655-2016·2016-02-17

    Fagron Recalls SyrSpend SF Grape Flavor Due to Yeast Contamination

    Fagron, Inc. is recalling SyrSpend SF Grape Flavor suspending base due to the presence of yeast. The recall affects 148 bottles distributed nationwide.

    Product
    SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0656-2016·2016-02-17

    Fagron Recalls SyrSpend SF Suspending Base Due to Yeast Contamination

    Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product contains yeast. The recall covers 88 bottles distributed nationwide.

    Product
    SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0654-2016·2016-02-17

    Fagron Recalls SyrSpend SF Syrup Due to Yeast Contamination

    Fagron, Inc. is recalling SyrSpend SF syrup-suspending vehicle due to the presence of yeast. The recall affects 44 bottles distributed nationwide.

    Product
    SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1497-2014·2014-08-06

    Fagron Recalls Pentravan Base Due to Mold Contamination

    Fagron is recalling six lots of Pentravan Base 2.5 Kg due to the presence of mold. The product is used for prescription compounding.

    Product
    Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1496-2014·2014-08-06

    Fagron Recalls Phytobase Cream Lots Due to Mold Contamination

    Fagron is recalling six lots of Phytobase Cream, a prescription compounding vehicle, due to the presence of mold.

    Product
    Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1498-2014·2014-08-06

    Fagron Recalls Pentravan Plus Base Due to Mold Contamination

    Fagron is recalling specific lots of Pentravan Plus Base, a prescription compounding ingredient, because of mold contamination.

    Product
    Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-fr
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Fagron

Czech company

Country
Czechoslovakia
Founded
1992

Source: Wikidata (Q134894855), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.