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.

Clear
DateProductReasonClassFirm
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.