Browse Drug Recalls
1,034 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,034 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 1,034 FDA drug recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2026 | CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, St... | Lack of assurance of sterility. The recall is due to potential contamination | Class II | Prestige Brands Holdings |
| Jul 28, 2026 | Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous ... | Lack of Assurance of Sterility | Class II | Regeneron Pharmaceuticals Inc |
| Jul 24, 2026 | Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose ... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged i... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, p... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 m... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL via... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packa... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT F... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Sing... | Presence of Particulate Matter: Product contaminated with particulate matter identified as glass ... | Class I | American Regent, Inc. |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT F... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC U... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Apr 20, 2026 | Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile... | Lack of Assurance of Sterility | Class II | SCOPE HEALTH |
| Mar 21, 2026 | Kian Pee Wan Capsules, 30-count bottles | Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone... | Class I | Buy-Herbal |
| 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. |
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.