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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 Mar 14, 2018

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart…

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

Oxygen Development LLC

FDA (openFDA drug enforcement)

Medical devices

Reported Mar 14, 2018

Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by…

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

Signature Orthopedics Pty Limited

FDA (openFDA device enforcement)

Medical devices

Reported Mar 7, 2018

Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

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

Baxter Healthcare Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Mar 7, 2018

Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are…

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

CooperVision Inc.

FDA (openFDA device enforcement)

Drugs

Reported Mar 7, 2018

Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc.,…

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

Leadiant Biosciences, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Mar 7, 2018

PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA…

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

Medline Industries Inc.

FDA (openFDA drug enforcement)

Food

Reported Mar 7, 2018

Seggiano Artichoke & Garlic Sauce & Spread Net Weight 200g, 7.1 oz, packaged in Glass jar, UPC Code: 812603020381

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

Seggiano USA Inc.

FDA (openFDA food enforcement)

Medical devices

Reported Feb 21, 2018

Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and…

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

ConforMIS, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Feb 14, 2018

Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson…

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

Mckesson Packaging Services

FDA (openFDA drug enforcement)

Food

Reported Feb 7, 2018

Clover Valley¿ Iced Oatmeal Cookies NET WT 12 OZ (340 g) CONTAINS: WHEAT, SOY. DISTRIBUTED BY DOLGENCORP, LLC 100…

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

Dollar General Corporation, Inc.

FDA (openFDA food enforcement)

Medical devices

Reported Feb 7, 2018

Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally…

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

Exactech, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Feb 7, 2018

Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital…

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

JCB Laboratories LLC

FDA (openFDA drug enforcement)

Drugs

Reported Feb 7, 2018

Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare,…

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

Medline Industries Inc.

67 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 31, 2018

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx…

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

Advanced Pharma Inc.

FDA (openFDA drug enforcement)

Food

Reported Jan 24, 2018

Old Fashioned Pecan Divinity; Net Wt. 8 OZ. (226g); Manufactured by Crown Candy Corporation; Confectionery product…

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

Crown Candy Corporation

1 more product in this recall

FDA (openFDA food enforcement)

Drugs

Reported Jan 24, 2018

ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes,…

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

Pharmedium Services, LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 17, 2018

Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine,…

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

Allergan

FDA (openFDA drug enforcement)

Medical devices

Reported Jan 17, 2018

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

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

Amendia, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Jan 10, 2018

diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1),…

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

Pfizer Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 27, 2017

NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged…

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

Advanced Pharma Inc.

6 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 27, 2017

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag,…

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

Claris Lifesciences Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 27, 2017

Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories,…

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

Osmotica Pharmaceutical Corp.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 27, 2017

Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only…

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

Premier Pharmacy Labs Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 27, 2017

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only,…

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

Renaissance Lakewood, LLC

FDA (openFDA drug enforcement)

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Related categories

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.