AbbVie Inc.
Complete recall history across all FDA and CPSC categories — 13 total recalls
Recall Summary
AbbVie Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (9)
FDA drug safety enforcement actions by AbbVie Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| 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... | Class II |
| 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... | Class II |
| 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 c... | Class III |
| 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 th... | Class III |
| 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 stor... | Class III |
| 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 stor... | Class III |
| 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 obtai... | Class II |
| Mar 24, 2016 | Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for Abb... | Failed Content Uniformity Specifications | Class III |
| Aug 1, 2013 | Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by ... | Labeling: Incorrect Package Insert; product packaged with outdated version of... | Class III |
Device Recalls (4)
FDA medical device enforcement actions by AbbVie Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 27, 2017 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | PEG kits have the potential for one of the following defects: missing compone... | Class II |
| Apr 27, 2017 | AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | Class II | |
| Apr 27, 2017 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | PEG kits have the potential for one of the following defects: missing compone... | Class II |
| Nov 22, 2016 | AbbVie PEG Kit 20 FR | AbbVie is issuing an urgent field correction notification due to an increased... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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