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 |
|---|---|---|---|---|
| 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 | 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 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 9, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... | Failed Impurity/Degradation Specifications | Class III | Lannett Company Inc. |
| Nov 9, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [... | 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 |
| Jul 22, 2022 | Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom... | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for... | Class III | Teva Pharmaceuticals USA Inc |
| Jul 20, 2022 | Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo... | Labeling: Label Error on Declared Strength | Class III | AVKARE Inc. |
| Jul 11, 2022 | Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Us... | Defective Container: Tube split from side seam | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jul 8, 2022 | Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.2... | Labeling: Missing label: the product tube was missing a label and contained a different formulation. | Class III | The Procter & Gamble Company |
| Jun 29, 2022 | Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bot... | Failed Tablet/Capsule Specification : Capsule breakage | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, H... | Failed Dissolution Specifications | Class III | Eco Lips, Inc |
| Jun 29, 2022 | Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant ... | Failed Dissolution Specifications | Class III | Eco Lips, Inc |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsul... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsu... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 16, 2022 | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC ... | Defective Container | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jun 3, 2022 | Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, R... | Failed impurity/degradation specifications: Out of specification for 2-HMP (a product leachable) ... | Class III | Akorn, Inc. |
| May 18, 2022 | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Cart... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class III | Teva Pharmaceuticals USA Inc |
| May 13, 2022 | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured ... | Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was print... | Class III | GlaxoSmithKline LLC |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Con... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Contai... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 3, 2022 | Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... | Class III | Apotex Corp. |
| May 3, 2022 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... | Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at... | Class III | American Health Packaging |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count b... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25... | Mislabeling: The active ingredient list on the label does not match the product's actual ingredie... | Class III | Eco Lips, Inc |
| Apr 27, 2022 | Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint ... | Subpotent drug: Low OOS for menthol content at the three month room temperature. | Class III | Bestco LLC |
| Apr 15, 2022 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... | Failed viscosity specification - product was below specificcation | Class III | Akorn, Inc. |
| Apr 14, 2022 | Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Man... | Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content | Class III | Monarch PCM, LLC |
| Apr 13, 2022 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... | cGMP deviations: Temperature abuse | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
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.