AbbVie recalls
FDA enforcement reports naming AbbVie Inc as the recalling firm.
- Recall reports
- 16
- Class I (serious)
- 0
- Most recent report
- Jun 3, 2026
- Jun 3, 2026PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0Drug · AbbVie Inc.Failed Stability SpecificationsClass III
- Oct 2, 2024Refresh PDrug · AbbVie Inc.Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.Class II
- Oct 2, 2024Refresh LACRI-LUBE, (42Drug · AbbVie Inc.Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.Class II
- Nov 15, 2023Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0Drug · AbbVie Inc.Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.Class III
- Feb 7, 2018Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie IncDrug · AbbVie Inc.Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.Class III
- Nov 1, 2017AndroGel (testosterone gel) 1Drug · AbbVie Inc.Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.Class III
- Nov 1, 2017AndroGel (testosterone gel) 1Drug · AbbVie Inc.Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.Class III
- Mar 8, 2017Duopa (carbidopa and levodopa enteral suspension), 4Drug · AbbVie Inc.Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated…Class II
- Apr 27, 2016Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie IncDrug · AbbVie Inc.Failed Content Uniformity SpecificationsClass III
- Oct 8, 2014CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bot…Drug · AbbVie IncPresence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.Class II
- Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit w…
- Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit w…
- Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit w…
- Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit w…
- LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration K…
- Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharm…
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