Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 12, 2021 | Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only,... | Failed Impurities/Degradation Specifications | Class III | American Health Packaging |
| May 7, 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent and Presence of Particulates . | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 4, 2021 | Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: ... | Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities | Class III | Dr. Reddy's Laboratories, Inc. |
| May 3, 2021 | Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 2... | Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 co... | Class III | Mylan Institutional LLC |
| Apr 29, 2021 | Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured b... | Presence of Foreign Tablet/Capsule | Class III | Ascend Laboratories LLC |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 27, 2021 | Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 ... | Failed Impurities/Degradation Specifications | Class III | KVK-Tech, Inc. |
| Apr 21, 2021 | Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Heritage Pharmaceuticals Inc |
| Apr 20, 2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total vo... | Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA)... | Class III | Genentech Inc |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laborator... | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... | Class III | SigmaPharm Laboratories LLC |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laborato... | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... | Class III | SigmaPharm Laboratories LLC |
| Apr 13, 2021 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein S... | Subpotent Drug | Class III | Nomax Inc |
| Mar 29, 2021 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent... | Failed Stability Specifications: product did not meet viscosity results. | Class III | Teligent Pharma, Inc. |
| Mar 25, 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottl... | Failed Moisture Limits: Out of specification for water content | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 22, 2021 | Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufact... | Failed Impurities/Degradation Specifications | Class III | Macleods Pharma Usa Inc |
| Mar 19, 2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Bli... | Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed ... | Class III | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
| Mar 18, 2021 | Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.... | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium... | Class III | Washington Homeopathic Products, Inc. |
| Mar 18, 2021 | LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by... | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium... | Class III | Washington Homeopathic Products, Inc. |
| Mar 18, 2021 | Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for:... | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium... | Class III | Washington Homeopathic Products, Inc. |
| Mar 9, 2021 | Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe ... | Temperature Abuse | Class III | Cardinal Health Inc. |
| Mar 4, 2021 | Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... | Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities... | Class III | Teva Pharmaceuticals USA |
| Mar 2, 2021 | Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vial... | Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP | Class III | Ferring Pharmaceuticals Inc |
| Feb 22, 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 19, 2021 | Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx... | Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosi... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Feb 19, 2021 | Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 5511... | Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and... | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 17, 2021 | Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Pres... | Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rath... | Class III | Edge Pharma, LLC |
| Feb 5, 2021 | Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distribute... | Failed Impurity/Degradation Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 2, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 gr... | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Class III | Teligent Pharma, Inc. |
| Feb 2, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 g... | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Class III | Teligent Pharma, Inc. |
| Feb 2, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr... | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Class III | Teligent Pharma, Inc. |
| Jan 29, 2021 | Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manuf... | Failed Dissolution Specifications | Class III | Akebia Therapeutics dba Keryx Biopharmaceutials... |
| Jan 28, 2021 | Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V... | Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo... | Class III | Accord Healthcare, Inc. |
| Jan 21, 2021 | Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume afte... | Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impu... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 15, 2021 | Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distribute... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class III | Calvin Scott & Company, Inc. |
| Jan 11, 2021 | Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL... | Incorrect Labeling: Incorrect lot number on secondary packaging | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 7, 2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, Inc. |
| Jan 7, 2021 | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, Inc. |
| Dec 23, 2020 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, ... | Presence of Foreign Substance: Particulate matter was found in multiple lots of product. | Class III | Genus Lifesciences Inc. |
| Dec 22, 2020 | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactur... | Failed Moisture Limits | Class III | Strides Pharma Inc. |
| Dec 22, 2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Edge Pharma, LLC |
| Dec 18, 2020 | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R... | Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i... | Class III | KVK-Tech, Inc. |
| Dec 17, 2020 | Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 m... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class III | SCA Pharmaceuticals |
| Dec 16, 2020 | Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ... | Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in... | Class III | US Compounding Inc |
| Nov 25, 2020 | Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit... | Labelling: Missing label. | Class III | US Compounding 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.