Browse Drug Recalls
1,678 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,678 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 1,678 FDA drug recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 10, 2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... | Subpotent Drug: Out of specification results for low potency was obtained. | Class III | SCA Pharmaceuticals |
| Mar 29, 2023 | Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-d... | Failed Impurities/Degradation Specifications: Above the specification limits yielded for related ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 29, 2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Class III | Accord Healthcare, Inc. |
| Mar 27, 2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Class III | Pine Pharmaceuticals, LLC |
| Mar 27, 2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Class III | Teva Pharmaceuticals USA Inc |
| Mar 16, 2023 | Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/m... | Labeling; Incorrect NDC number on outer carton of product. | Class III | Focus Health Group Inc |
| Mar 9, 2023 | Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured... | Failed Content Uniformity Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 8, 2023 | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed ... | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry... | Class III | Pfizer Inc. |
| Feb 24, 2023 | Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed d... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Feb 24, 2023 | Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentratio... | Subpotent Drug | Class III | SCA Pharmaceuticals |
| Feb 21, 2023 | Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f... | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Stan... | Class III | Padagis US LLC |
| Feb 17, 2023 | Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured... | Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800... | Class III | Sciegen Pharmaceuticals Inc |
| Feb 17, 2023 | DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Akron Pharma, Inc. |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 2, 2023 | Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First ai... | Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. | Class III | Advantice Health, Llc |
| Feb 1, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/G... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Feb 1, 2023 | Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Feb 1, 2023 | BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross W... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Feb 1, 2023 | Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Jan 30, 2023 | Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The ... | Failed Stability Specifications: Out of specification test results for viscosity was identified a... | Class III | Akorn, Inc. |
| Jan 20, 2023 | Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for:... | Subpotent Drug: Low assay result observed during long-term stability testing. | Class III | Lupin Pharmaceuticals Inc. |
| Jan 13, 2023 | FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free ... | Short Fill: Underfilled units. | Class III | OurPharma LLC |
| Jan 5, 2023 | Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for... | Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package inse... | Class III | MACLEODS PHARMA USA, INC |
| Jan 4, 2023 | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx ... | Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dis... | Class III | Intersect ENT, Inc. |
| Dec 27, 2022 | Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... | Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Dec 21, 2022 | Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote... | Failed Stability Specifications: Out of specification for weight loss at the 18-month stability t... | Class III | Apotex Corp. |
| Dec 6, 2022 | Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Onl... | Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid c... | Class III | Camber Pharmaceuticals, Inc |
| Nov 21, 2022 | Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 14, 2022 | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleans... | Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. | Class III | Acella Pharmaceuticals, LLC |
| Nov 14, 2022 | Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 1... | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... | Class III | Acella Pharmaceuticals, LLC |
| Nov 14, 2022 | Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10... | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... | Class III | Acella Pharmaceuticals, LLC |
| Nov 9, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [... | Failed Impurity/Degradation Specifications | Class III | Lannett Company Inc. |
| Nov 9, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... | Failed Impurity/Degradation Specifications | Class III | Lannett Company Inc. |
| Oct 18, 2022 | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton contain... | Defective Delivery System: Commercial implants do not meet the filed specification for the intend... | Class III | Genentech Inc |
| Oct 13, 2022 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-... | Failed Stability Specifications | Class III | Aadi Bioscience |
| Oct 11, 2022 | NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN ... | Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg | Class III | LNK International, Inc. |
| Sep 26, 2022 | Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dos... | Presence of Particulate Matter: Piece of metal found in a vial | Class III | AuroMedics Pharma LLC |
| Sep 20, 2022 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injec... | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride ... | Class III | QuVa Pharma, Inc. |
| Sep 19, 2022 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manu... | Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 ... | Class III | UNICHEM PHARMACEUTICALS USA INC |
| Sep 16, 2022 | Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT L... | Failed Viscosity specification: Slightly higher OOS results obtained for viscosity | Class III | ALMIRALL, LLC |
| Sep 14, 2022 | Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules ... | Failed Stability Specifications: Out of specification results reported at 12-month stability test... | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 30, 2022 | Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon S... | Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. | Class III | Woodbine Products Co Inc |
| Aug 23, 2022 | ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LE... | Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules | Class III | Leading Pharma, LLC |
| Aug 8, 2022 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials,... | Identification of an unknown impurity at the 12-month stability point. Further investigation has ... | Class III | Akorn, Inc |
| Aug 4, 2022 | Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blist... | Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate... | Class III | LNK International, Inc. |
| Aug 4, 2022 | Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle ... | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Class III | Akron Pharma, Inc. |
| Aug 4, 2022 | Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-802... | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Class III | Akron Pharma, Inc. |
| Aug 2, 2022 | Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam ... | Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of ... | Class III | HERON THERAPEUTICS, INC. |
| Jul 27, 2022 | Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx O... | Subpotent Drug | Class III | Amerisource Health Services LLC |
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.