Fagron, Inc
Complete recall history across all FDA and CPSC categories — 22 total recalls
Fagron, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (22)
FDA drug safety enforcement actions by Fagron, Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 11, 2023 | NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... | Labeling: Label Error on Declared Strength: Assay value on the label is incor... | Class II |
| Dec 11, 2023 | NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Onl... | Labeling: Label Error on Declared Strength: Assay value on the label is incor... | Class II |
| Dec 11, 2023 | NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... | Labeling: Label Error on Declared Strength: Assay value on the label is incor... | Class II |
| Dec 11, 2023 | NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only... | Labeling: Label Error on Declared Strength: Assay value on the label is incor... | Class II |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III |
| Mar 4, 2022 | SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (N... | Microbial Contamination of Non-Sterile Product: Product is contaminated with ... | Class I |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III |
| Oct 31, 2019 | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Po... | Microbial contamination of non-sterile product. | Class II |
| Feb 14, 2018 | SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 515... | Microbial contamination of Non-Sterile Product; product contamination with y... | Class II |
| Oct 25, 2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552... | cGMP Deviations: lack of quality assurance at the API manufacturer. | Class II |
| Apr 17, 2017 | Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pi... | Labeling: Error on Declared Strength: Error is due to an incorrect value in t... | Class III |
| Apr 6, 2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-... | cGMP Deviations: lack of quality assurance at the API manufacturer. | Class II |
| Apr 6, 2017 | Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-... | cGMP Deviations: lack of quality assurance at the API manufacturer. | Class II |
| Nov 11, 2015 | SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-... | Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF ... | Class II |
| Nov 11, 2015 | SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspe... | Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF ... | Class II |
| Nov 11, 2015 | SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle spe... | Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF ... | Class II |
| Jul 24, 2014 | Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescri... | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots... | Class II |
| Jul 24, 2014 | Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For pr... | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots... | Class II |
| Jul 24, 2014 | Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescr... | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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