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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
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.
Mar 21, 2022 quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 21, 2022 quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, ... CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the accepta... Class II Pfizer Inc.
Mar 14, 2022 Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag,... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chl... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, ... Defective container Class II Athenex Pharma Solutions, LLC
Mar 14, 2022 Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL ex... Defective container Class II Athenex Pharma Solutions, LLC
Feb 25, 2022 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... Class III Taro Pharmaceuticals U.S.A., Inc.
Feb 8, 2022 MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 8, 2022 RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tad... Class I Celebrate Today
Feb 8, 2022 MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLD... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton togethe... Non-sterility Class I CooperSurgical, Inc
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, 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.