AbbVie Inc. recalls PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North…
Failed Stability Specifications
Read the official notice →- Date
- 2026-06-03
- Country
- United States
- Brand
- AbbVie
- Product
- PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North…
- Classification
- Class III
- Units
- US Nationwide.
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More AbbVie recalls
- 2024-10-02
USAbbVie Inc. recalls Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen,…
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
FDA · DrugAbbVie Inc.Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)Official notice →- 2023-11-15
- US
AbbVie Inc. recalls Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC…
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.
Other drugs & medical recalls in the United States
- 2026-06-03
- US
O&M HALYARD INC recalls Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
FDA · DeviceO&M HALYARD INCUS Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.Official notice → - US
Abiomed, Inc. recalls Automated Impella Controller (AIC); Product Code: 0042-0000-US;
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process;…
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA,…Official notice → - US
Bolton Medical Inc. recalls RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U…
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
FDA · DeviceBolton Medical Inc.Worldwide - distribution in the US Territory of Puerto Rico and the countries…Official notice → - US
AVEVA Drug Delivery Systems, Inc. recalls Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN…
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- 2026-05-27
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12…
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia,…Official notice → - US
C.R. Bard Inc recalls Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF:…
Due to stain present on the surface of affected foley catheters.
FDA · DeviceC.R. Bard IncU.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,…Official notice →