Browse Drug Recalls
17 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17 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 17 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2024 | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Sep 16, 2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointm... | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | Class II | AbbVie Inc. |
| Oct 17, 2023 | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bott... | Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect bar... | Class III | AbbVie Inc. |
| Mar 15, 2021 | Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix s... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Jan 22, 2018 | Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by... | Defective container: presence of a hole in the liners of the caps covering the product bottle, in... | Class III | AbbVie Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testo... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Pa... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Jan 13, 2017 | Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... | Failed Stability Specifications: confirmed out of specification results obtained during refrigera... | Class II | AbbVie Inc. |
| Mar 24, 2016 | Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for Abb... | Failed Content Uniformity Specifications | Class III | AbbVie Inc. |
| Sep 15, 2014 | CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 C... | Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000. | Class II | AbbVie Inc |
| Mar 10, 2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... | Class II | AbbVie Inc |
| Mar 10, 2014 | LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Admini... | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... | Class II | AbbVie Inc |
| Mar 10, 2014 | Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administra... | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... | Class II | AbbVie Inc |
| Mar 10, 2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... | Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defe... | Class II | AbbVie Inc |
| Mar 10, 2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... | Class II | AbbVie Inc |
| Aug 1, 2013 | Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by ... | Labeling: Incorrect Package Insert; product packaged with outdated version of the insert | Class III | AbbVie 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.