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 7, 2023 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 7, 2023 | Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jun 5, 2023 | Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufa... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaL... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Ge... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distr... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: Ste... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distribute... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distr... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distribu... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| Jun 5, 2023 | Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New Y... | cGMP deviations | Class II | Homeocare Laboratories, Inc. |
| May 30, 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo... | Failed Dissolution Specifications: Out-of-specification results for dissolution (above specificat... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 8, 2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... | Class III | Amneal Pharmaceuticals of New York, LLC |
| 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 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 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 |
| Jan 17, 2023 | Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 M... | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | Urban Electric Power |
| Jan 17, 2023 | Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | Urban Electric Power |
| Dec 29, 2022 | Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium... | Lack of assurance of sterility: Bags have the potential to leak. | Class II | Pfizer Inc. |
| Dec 22, 2022 | Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular In... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Pine Pharmaceuticals, LLC |
| Dec 22, 2022 | Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Sing... | Presence of Particulate Matter: Glass particulate matter detected in injectable. | Class I | Pfizer Inc. |
| 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 27, 2022 | Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose via... | Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. | Class II | Pfizer Inc. |
| Aug 22, 2022 | PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass... | Presence of particulate matter | Class I | Pfizer 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. |
| Jul 27, 2022 | Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-coun... | Failed dissolution specifications. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jul 27, 2022 | Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar ... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Jul 25, 2022 | FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV b... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 25, 2022 | fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) ... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 13, 2022 | Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per g... | Presence of particulate matter: particulate identified as a beetle. | Class I | Pfizer Inc. |
| Jun 27, 2022 | Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code ... | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Class II | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPW... | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Class II | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ... | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Class II | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code ... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... | Class I | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPW... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... | Class I | Loud Muscle Science |
| Jun 27, 2022 | Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredie... | Class I | Loud Muscle Science |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 22, 2022 | Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 ... | CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. | Class II | Pfizer Inc. |
| Apr 4, 2022 | BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Ha... | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Class II | Beak & Skiff Cider Mill, Inc. |
| Mar 29, 2022 | The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Be... | Chemical Contamination; FDA analysis found product to contain benzene | Class I | Best Brands Consumer Products, Inc. |
| Mar 29, 2022 | Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best B... | Chemical Contamination; FDA analysis found product to contain methanol | Class I | Best Brands Consumer Products, Inc. |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablet... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... | Class II | Pfizer Inc. |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tabl... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... | Class II | Pfizer Inc. |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablet... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... | Class II | Pfizer Inc. |
| Mar 21, 2022 | quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only,... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... | Class II | Pfizer Inc. |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tab... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... | Class II | Pfizer Inc. |
| Mar 21, 2022 | Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tab... | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... | 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.