Browse Drug Recalls
22 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 22 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 22 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 incorrect. | Class II | Fagron, Inc |
| 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 incorrect. | Class II | Fagron, Inc |
| 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 incorrect. | Class II | Fagron, Inc |
| 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 incorrect. | Class II | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III | Fagron, Inc |
| 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 Burkholderia gladioli. | Class I | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III | Fagron, Inc |
| 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 | Fagron, Inc |
| 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 yeast and mold (Paeci... | Class II | Fagron, Inc |
| 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 | Fagron, Inc |
| 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 the Drug Facts Panel.... | Class III | Fagron, Inc |
| 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 | Fagron, Inc |
| 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 | Fagron, Inc |
| Nov 11, 2015 | SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-... | Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are bei... | Class II | Fagron, Inc |
| 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 Grape Flavor are bei... | Class II | Fagron, Inc |
| 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 Grape Flavor are bei... | Class II | Fagron, Inc |
| 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 due to the presence... | Class II | Fagron, Inc |
| 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 due to the presence... | Class II | Fagron, Inc |
| 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 due to the presence... | Class II | Fagron, Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.