Drug recalls, 2026-W23

FDA drug recalls, June 1 to 7, 2026

FDA posted 2 drug recalls the week of June 1, 2026: 2 Class III.

License: openFDA publishes this file under CC0 1.0.

FDA sorts recalls by risk. Class I: using the product could cause serious health problems or death. Class II: it could cause temporary or reversible health problems. Class III: it is unlikely to cause health problems.

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Recalls posted June 1 to 7, 2026

Class III · Posted June 3, 2026 · Started May 18, 2026 · Ongoing

prednisolone acetate

Product: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
Firm: AbbVie Inc., North Chicago, IL
Reason: Failed Stability Specifications
Lots: Lot # 402805, 407596, Exp Date: 08/2026.
Quantity: 2,736 bottles
Distribution: US Nationwide.
RxNorm: prednisolone acetate (RxCUI 209002, 562379)
Recall number: D-0551-2026

Class III · Posted June 3, 2026 · Started May 14, 2026 · Ongoing

nicotine

Product: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Firm: AVEVA Drug Delivery Systems, Inc., Miramar, FL
Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Lots: Lot #: 56841, Expires: 03/2028
Quantity: 59,808 pouches (4,272 Individual Folding Carton (IFC))
Distribution: Nationwide within the U.S
RxNorm: nicotine (RxCUI 198029, 198030, 198031)
Recall number: D-0550-2026

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

About this data

Each row is one FDA drug enforcement report: one product from one firm. A week here is Monday to Sunday, keyed on the date FDA listed the recall in its weekly Enforcement Report. The date the firm started the recall is shown on each row and is often weeks earlier.

Class I means use of the product could cause serious health problems or death. Class II means it could cause temporary or reversible health problems. Class III means it is unlikely to cause health problems. RxNorm names and RxCUIs come from openFDA's match of the product to its drug label. Compounded products often have no match.

This page lists public records. It is not medical advice. Check the FDA record before acting on a recall.