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Labeling and dosing error recalls

Nothing is contaminated in these recalls — the package says the wrong thing. That can mean a bottle holding a different strength than the label states, two products packed in the wrong carton, or missing directions. For medication these can matter as much as contamination, because the dose taken is the wrong one.

983 stored notices, reported between Jun 20, 2012 and Nov 11, 2026. Newest first.

Drugs

Reported Apr 13, 2022

Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc.,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mylan Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Apr 13, 2022

Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box,…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Sun Pharmaceutical Industries Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Apr 6, 2022

Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only,…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Jubilant Cadista Pharmaceuticals, Inc.

FDA (openFDA drug enforcement)

Food

Reported Apr 6, 2022

Tam's Homemade Biscuits 8 count packaged in 9 inch round aluminum cake pan 10 pans per case

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Tam's Homemade Biscuits Inc.

FDA (openFDA food enforcement)

Medical devices

Reported Mar 16, 2022

HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Maquet Cardiovascular, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Mar 9, 2022

Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

ROi CPS LLC

FDA (openFDA device enforcement)

Drugs

Reported Mar 2, 2022

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AMS Packaging Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Mar 2, 2022

Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E.…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

FDA (openFDA drug enforcement)

Food

Reported Mar 2, 2022

Dunkin Caramel Swirl: 6x 64 fl. oz. per case. Product number 4862 UPC case: 10045796048628 Ingredients: Sweetened…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Lyons Magnus, Inc.

FDA (openFDA food enforcement)

Medical devices

Reported Mar 2, 2022

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stryker Sustainability Solutions

FDA (openFDA device enforcement)

Medical devices

Reported Feb 23, 2022

FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Envisiontec US LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 23, 2022

KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Microbiologics Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Feb 9, 2022

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Olympus Corporation of the Americas

FDA (openFDA device enforcement)

Drugs

Reported Feb 2, 2022

Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Aurobindo Pharma USA Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Feb 2, 2022

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Dental Alliance Holdings LLC

6 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Jan 26, 2022

Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Straumann USA LLC

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Jan 5, 2022

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only,…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Teligent Pharma, Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 29, 2021

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Coloplast Manufacturing US, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Dec 29, 2021

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Maquet Cardiovascular, LLC

FDA (openFDA device enforcement)

Drugs

Reported Dec 29, 2021

Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Teva Pharmaceuticals USA

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 22, 2021

Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Cook Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Dec 22, 2021

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Teligent Pharma, Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 22, 2021

Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

TOLMAR, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 22, 2021

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Torrent Pharma Inc.

FDA (openFDA drug enforcement)

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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.