Browse Drug Recalls
20 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 20 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 20 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2025 | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in... | Temperature Abuse | Class II | Sandoz Inc |
| Mar 21, 2022 | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Table... | CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. | Class II | Sandoz, Inc |
| Mar 15, 2021 | Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Apr 21, 2020 | Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1... | Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins | Class II | Sandoz, Inc |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactur... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... | Class II | Sandoz, Inc |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactu... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... | Class II | Sandoz, Inc |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactur... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... | Class II | Sandoz, Inc |
| Nov 1, 2018 | Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Sandoz, Inc |
| Apr 6, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... | Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... | Class III | Sandoz Incorporated |
| Jan 4, 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... | Supotent: Out of Specification result for assay test during routine stability testing. | Class III | Mckesson Packaging Services |
| Nov 9, 2016 | L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Packag... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| May 2, 2016 | Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufa... | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... | Class III | Sandoz, Inc |
| May 2, 2016 | Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufa... | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... | Class III | Sandoz, Inc |
| Apr 15, 2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli... | Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported f... | Class III | Sandoz, Inc |
| Oct 2, 2014 | candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated ... | Class III | Sandoz, Inc |
| Jul 30, 2014 | Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: S... | Presence of Foreign Substance; tablets may contain stainless steel metal particulates | Class II | Mckesson Packaging Services |
| May 22, 2014 | Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufa... | Presence of Foreign Substance: Presence of stainless steel particles. | Class II | Sandoz, Inc |
| Oct 9, 2013 | Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufac... | Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended ... | Class II | Sandoz, Inc |
| Oct 2, 2013 | Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... | Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE... | Class III | Cardinal Health |
| May 30, 2013 | Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, si... | Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, ... | Class II | Sandoz Incorporated |
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.