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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.

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

Medical devices

In the agency's Nov 11, 2026 enforcement report

EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106

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

Smith & Nephew, Inc.

FDA (weekly enforcement report)

Drugs

In the agency's Nov 4, 2026 enforcement report

Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC…

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

Direct Rx

FDA (weekly enforcement report)

Drugs

In the agency's Nov 4, 2026 enforcement report

ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc.…

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

Prodose, Inc.

FDA (weekly enforcement report)

Food

Reported Oct 28, 2026Updated Nov 2, 2026

Evexias Health Solutions Amino Ultra, 90-capsules, dietary supplement in white plastic bottles with blue/green/white…

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

Evexias Health Solution

FDA (openFDA food enforcement)

Drugs

Reported Oct 28, 2026Updated Nov 2, 2026

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc.,…

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

Pfizer

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Oct 28, 2026Updated Nov 2, 2026

Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals…

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

Viatris, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 21, 2026Updated Oct 26, 2026

REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm

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

In2bones USA, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Oct 21, 2026Updated Oct 26, 2026

Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product…

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

W L Gore & Associates, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 7, 2026Updated Oct 13, 2026

Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex…

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

Micro Therapeutics, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Sep 30, 2026Updated Oct 7, 2026

Cornea

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

San Antonio Eye Bank

FDA (weekly enforcement report)

Drugs

Reported Sep 23, 2026Updated Sep 29, 2026

Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg,…

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

Vitruvias Therapeutics Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Sep 16, 2026Updated Sep 22, 2026

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only,…

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

ImprimisRx NJ LLC

FDA (openFDA drug enforcement)

Drugs

Reported Sep 9, 2026Updated Sep 14, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl.…

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

Allies Group Inc.

3 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Sep 2, 2026Updated Sep 27, 2026

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,…

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

Accord Healthcare, Inc.

11 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Aug 24, 2026Updated Sep 17, 2026

Vitruvias Therapeutics, Inc recalls Vitruvias Therapeutics Thyroid Tablets, USP 30 mg due to Potential for the Product to be Superpotent

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

Vitruvias Therapeutics, Inc.

FDA (recalls & safety alerts)

Medical devices

Reported Aug 12, 2026

Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

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

Freudenberg Medical, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Jul 29, 2026

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only,…

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

Major Pharmaceuticals

11 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Jul 29, 2026

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm…

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

Micro Therapeutics, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Jul 22, 2026

CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe &…

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

Bell Pharmaceuticals, Inc.

10 more products in this recall

FDA (openFDA drug enforcement)

Food

Reported Jul 22, 2026

functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ…

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

Nutricia North America

1 more product in this recall

FDA (openFDA food enforcement)

Drugs

Reported Jul 22, 2026

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham,…

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

Padagis US LLC

FDA (openFDA drug enforcement)

Drugs

Reported Jul 15, 2026

Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo…

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

Gasco Industrial Corp.

5 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jul 8, 2026

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare,…

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

Accord Healthcare, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jul 1, 2026

Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and…

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

The Harvard Drug Group LLC

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.