Browse Drug Recalls
26 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 26 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 26 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 10, 2025 | KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusi... | Subpotent Drug | Class II | IMMUNOCORE, LLC |
| Feb 15, 2023 | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL... | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Class II | Azurity Pharmaceuticals, Inc. |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Con... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| Feb 4, 2021 | Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wi... | Failed Dissolution Specifications | Class II | Wilshire Pharmaceuticals Inc |
| Feb 4, 2021 | Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: ... | Failed Dissolution Specifications | Class II | Wilshire Pharmaceuticals Inc |
| Sep 27, 2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose,... | Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1... | Class III | Arbor Pharmaceuticals Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartri... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartri... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartr... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, ... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 6, 2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... | Class I | Darmerica, LLC |
| May 18, 2017 | Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx on... | Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually ... | Class II | Forest Laboratories, LLC |
| Mar 17, 2017 | Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, D... | Presence of Particulate Matter: Glass | Class II | Shire |
| Dec 2, 2016 | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, R... | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 25... | Class III | Shire PLC |
| Sep 2, 2016 | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx On... | Presence of Foreign Tablets/Capsules | Class III | Shire |
| Jun 2, 2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only... | Presence of Particulate Matter: Product failed the appearance for the presence of visible particl... | Class I | Alexion Pharmaceuticals, Inc. |
| Mar 14, 2014 | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/via... | Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. | Class I | Shire Human Genetic Therapies, Inc. |
| Nov 4, 2013 | Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300... | Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. | Class I | Alexion Pharmaceuticals, Inc. |
| Aug 1, 2013 | Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Via... | Presence of particulate matter: characterized as thin colorless flakes that are visually and chem... | Class II | Nexus Pharmaceuticals Inc |
| Apr 24, 2012 | Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and I... | Presence of Particulate Matter | Class II | Luitpold Pharmaceuticals, Inc. |
| Mar 22, 2012 | Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 ho... | Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel forc... | Class II | Noven Pharmaceuticals, Inc. |
| Jul 5, 2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... | Class II | Noven Pharmaceuticals, Inc. |
| Jul 5, 2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho... | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... | Class II | Noven Pharmaceuticals, Inc. |
| Jul 5, 2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... | Class II | Noven Pharmaceuticals, Inc. |
| Jul 5, 2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho... | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... | Class II | Noven Pharmaceuticals, 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.