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.
Reported Aug 5, 2020
Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Allergan PLC
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 5, 2020
Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.World Event Promotions, LLC
FDA (openFDA drug enforcement)
Reported Jul 29, 2020
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Lupin Pharmaceuticals Inc.
FDA (openFDA drug enforcement)
Reported Jul 22, 2020
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Access Scientific LLC
FDA (openFDA device enforcement)
Reported Jul 22, 2020
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
FDA (openFDA drug enforcement)
Reported Jul 22, 2020
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Neocis Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperSurgical, Inc.
FDA (openFDA device enforcement)
Reported Jul 8, 2020
Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beaming White LLC
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 8, 2020
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho Organizers, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2020
Isolation Droplet Bundle Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ROi CPS LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2020
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Crown Laboratories
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 24, 2020
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasol, Inc.
FDA (openFDA device enforcement)
Reported Jun 24, 2020
EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Eco Lips Inc.
FDA (openFDA drug enforcement)
Reported Jun 24, 2020
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
FDA (openFDA drug enforcement)
Reported Jun 17, 2020
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ormco/Sybronendo
FDA (openFDA device enforcement)
Reported Jun 17, 2020
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.QuVa Pharma, Inc.
FDA (openFDA drug enforcement)
Reported Jun 10, 2020
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Acella Pharmaceuticals, LLC
2 more products in this recall
FDA (openFDA drug enforcement)
Reported May 27, 2020
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
FDA (openFDA device enforcement)
Reported May 27, 2020
Willamette Valley Pie Company Raspberry Rhubarb Pie, packaged in clamshells container, six containers per case. Each…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Willamette Valley Pie Company, LLC.
1 more product in this recall
FDA (openFDA food enforcement)
Reported May 20, 2020
The product is twisted bread and packaged in a flexible plastic bag with a yellow Kwik-Lok seal. The label is read in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Essential Baking Company, The
FDA (openFDA food enforcement)
Reported May 20, 2020
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported May 20, 2020
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W. L. Gore & Associates Inc.
FDA (openFDA device enforcement)
Reported May 13, 2020
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Trilliant Surgical, LLC
FDA (openFDA device enforcement)
Reported May 6, 2020
Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
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