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AbbVie Inc. FDA Recalls

4 recalls on file across drugs, 0 of them Class I and 4 still open. Matched by name to ABBV.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie coClass IIIMay 18, 2026Failed Stability Specifications
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, DistributClass IISep 16, 2024Lack of Assurance of Sterility: The impacted lots may contai
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, DisClass IISep 16, 2024Lack of Assurance of Sterility: The impacted lots may contai
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 6Class IIIOct 17, 2023Labeling: Wrong Barcode- One (1) of every forty (40) unit do

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