PlainRecalls

Fagron, Inc

22 recalls on record · Latest: Dec 27, 2023

Fagron, Inc Recall Insight

Fagron, Inc appears on 22 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.026% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 27, 2023, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 22 entries, severity tagging shows 1 critical, 15 moderate, and 6 lower-severity recalls. Affected-unit counts are disclosed on 21 of 22 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 3 distinct product categories, with issuing agencies dominated by FDA Drug (22). The date window on this page runs from Aug 6, 2014 to Dec 27, 2023.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Drug Moderate Dec 27, 2023

NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St P…

FDA Drug Moderate Dec 27, 2023

NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. S…

FDA Drug Moderate Dec 27, 2023

NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St …

FDA Drug Moderate Dec 27, 2023

NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. S…

FDA Drug Low May 18, 2022

Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. N…

FDA Drug Low May 18, 2022

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX…

FDA Drug Low May 18, 2022

Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. …

FDA Drug Low May 18, 2022

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. N…

FDA Drug Critical May 18, 2022

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, Manufac…

FDA Drug Low May 18, 2022

Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX …

FDA Drug Moderate Dec 11, 2019

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate -…

FDA Drug Moderate Mar 7, 2018

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

FDA Drug Moderate Nov 22, 2017

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-…

FDA Drug Moderate May 31, 2017

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: 51552-0…

FDA Drug Moderate May 31, 2017

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-…

FDA Drug Low May 10, 2017

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

FDA Drug Moderate Feb 17, 2016

SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid…

FDA Drug Moderate Feb 17, 2016

SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparati…

FDA Drug Moderate Feb 17, 2016

SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extempor…

FDA Drug Moderate Aug 6, 2014

Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil…

FDA Drug Moderate Aug 6, 2014

Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO ge…

FDA Drug Moderate Aug 6, 2014

Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds