All recall categories

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.

972 stored notices, reported between Jun 20, 2012 and Sep 23, 2026. Newest first.

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)

Drugs

Reported Dec 8, 2021

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium…

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

Lupin Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Nov 24, 2021

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals…

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

Amneal Pharmaceuticals

1 more product in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Nov 10, 2021

The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate…

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

Bayer Medical Care, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 10, 2021

GM Helix Acqua Implant 3.5x10, Article No. 140.944

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

Jjgc Industria E Comercio De Materials Dentarios Sa

FDA (openFDA device enforcement)

Drugs

Reported Oct 27, 2021

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale,…

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

Teva Pharmaceuticals USA

4 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Oct 20, 2021

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe.…

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

Eli Lilly & Company

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 20, 2021

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON…

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 6, 2021

Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term…

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

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA (openFDA device enforcement)

Drugs

Reported Oct 6, 2021

Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime…

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

New Vision Pharmaceuticals LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Sep 29, 2021

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution…

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

Avrio Health L.p

FDA (openFDA drug enforcement)

Drugs

Reported Sep 22, 2021

Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New…

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

Teligent Pharma, Inc.

FDA (openFDA drug enforcement)

Free recall alerts

Get alerted about new Labeling and dosing errors recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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.