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Browse Drug Recalls

21 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 21 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 21 FDA drug recalls.

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DateProductReasonClassFirm
Oct 10, 2025 Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile,... Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. Class II Safecor Health, LLC
Oct 7, 2022 Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. Class I Viatris Inc
Sep 21, 2022 Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 ... Presence of Particulate Matter: A complaint was received for the presence of a single strand of h... Class II Viatris Inc
Apr 7, 2022 Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manuf... Failed Impurities/Degradation Specifications: High out of specification results obtained for rela... Class II Mylan Pharmaceuticals Inc
May 3, 2021 Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 2... Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 co... Class III Mylan Institutional LLC
Aug 17, 2020 Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 17, 2020 Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Jul 7, 2020 Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma... Presence of Particulate Matter Class I Mylan Institutional LLC
May 5, 2020 Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,... Discoloration: Out-of-specification results for appearance obtained during routine stability test... Class II Mylan Institutional LLC
Oct 7, 2019 Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan I... Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity resu... Class II Mylan Laboratories Limited (Sterile Products Di...
Feb 1, 2019 Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx... Presence of Particulate Matter: particulate matter identified as copper salts Class I Mylan Institutional Inc
Apr 23, 2015 Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Mul... Presence of Particulate Matter Class I Mylan Institutional LLC
Feb 18, 2015 Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL ... Lack of Assurance of Sterility; due to leaking vials Class II Mylan Institutional LLC
Feb 18, 2015 Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL... Lack of Assurance of Sterility; due to leaking vials Class II Mylan Institutional LLC
Feb 11, 2015 DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use... Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may... Class III Mylan Institutional LLC
Jan 23, 2015 Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dos... Subpotent Drug and Failed Impurities/Degradation Specifications Class III Mylan Institutional LLC

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.