AbbVie Inc.

Complete recall history across all FDA and CPSC categories — 13 total recalls

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 Labeling: Incorrect Package Insert; product packaged with outdated version of...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.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.