Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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DateProductReasonClassFirm
Dec 9, 2025 Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., O... Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint Class II SUN PHARMA /TARO
Oct 17, 2025 Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet f... Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly state... Class II Aero Healthcare
Oct 3, 2025 TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only,... Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. Class II Advanced Pharmaceutical Technology, Inc.
Aug 5, 2025 Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL... Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W... Class III Haleon US Holdings LLC
Aug 4, 2025 Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R... Lack of Assurance of Sterility. Class II PFIZER INC
Aug 4, 2025 Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri... Lack of Assurance of Sterility. Class II PFIZER INC
Jul 29, 2025 Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx onl... Subpotent drug Class II Pfizer
Jul 10, 2025 Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... CGMP Deviations; particulates identified during visual inspection Class II Pfizer Inc.
Jul 10, 2025 Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... CGMP Deviations; particulates identified during visual inspection Class II Pfizer Inc.
Jul 9, 2025 Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides... Failed Dissolution Specifications. Class II Strides Pharma, Inc.
May 30, 2025 TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml ... Marketed Without an Approved NDA/ANDA Class II Advanced Pharmaceutical Technology, Inc.
May 28, 2025 DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose V... Discoloration; discolored solution from cracked vials Class II Pfizer Inc.
Mar 12, 2025 Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), D... Chemical contamination: Presence of benzene Class II Alchemee, LLC
Mar 12, 2025 Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 ... Chemical contamination: Presence of benzene Class II Alchemee, LLC
Mar 5, 2025 Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, D... Presence of foreign substance: Presence of Benzene. Class II Strides Pharma, Inc.
Mar 5, 2025 Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Dist... Presence of foreign substance: Presence of Benzene. Class II Strides Pharma, Inc.
Jan 28, 2025 SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Jan 28, 2025 SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 m... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Jan 28, 2025 SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP... Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus Class I Ascent Consumer Products Inc.
Dec 12, 2024 FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO AL... Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofen... Class I GNMart LLC
Dec 12, 2024 Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured... Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undecla... Class I Buy-Herbal
Nov 22, 2024 VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net... CGMP deviations: out of specifications for assay Class II Apothecus Pharmaceutical Corp.
Nov 15, 2024 Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by... Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 ... Class II Evaric Pharmaceuticals Inc.
Nov 14, 2024 Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister ... CGMP Deviations: Released product should have been rejected. Class II LNK International, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Oct 21, 2024 Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Ath... Superpotent Drug: Stability failure for assay at 6 months test time-point. Class II BLI International, Inc.
Aug 7, 2024 Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related i... Class III Taro Pharmaceuticals U.S.A., Inc.
Jun 26, 2024 Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML... CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. Class II Equibal Inc
Jun 5, 2024 STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distri... Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms Class I Homeocare Laboratories, Inc.
Jun 5, 2024 STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473... Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism Class II Homeocare Laboratories, Inc.
May 20, 2024 Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By:... Discoloration: Brownish tablets Class II Contract Pharmacal Corporation
May 20, 2024 Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpu... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer Inc.
May 20, 2024 Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dos... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer Inc.
May 15, 2024 EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a... Lack of Assurance of Sterility: Complaints of syringe breakage Class II Regeneron Pharmaceuticals Inc
Apr 23, 2024 EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-d... Lack of Assurance of Sterility: Complaints of syringe breakage Class II Regeneron Pharmaceuticals Inc
Apr 2, 2024 Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Mar 25, 2024 Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... Failed Dissolution Specifications Class II Amneal Pharmaceuticals of New York, LLC
Mar 21, 2024 Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... Superpotent Drug: Due to overfilling of drug powder Class I Amneal Pharmaceuticals of New York, LLC
Mar 21, 2024 VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9... cGMP Diviations Class II Apothecus Pharmaceutical Corp.
Feb 13, 2024 Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottl... Failed Impurities/Degradation Specifications: Out-of-specification test results. Class II Amneal Pharmaceuticals of New York, LLC
Feb 12, 2024 ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-c... Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... Class I FA Online Inc
Feb 5, 2024 Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, D... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Super Chill Products
Feb 1, 2024 TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... Chemical Contamination; presence of benzene. Class I Insight Pharmaceuticals LLC, a Prestige Consume...
Jan 17, 2024 Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Pack... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouc... Class II Henry Schein Inc. and Glove Club HSI Gloves Inc.
Jan 15, 2024 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,... Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class II Amneal Pharmaceuticals of New York, LLC
Dec 28, 2023 Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guai... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydro... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma 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.