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.
Reported Oct 7, 2020
Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Arbor Pharmaceuticals Inc.
FDA (openFDA drug enforcement)
Reported Oct 7, 2020
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Encore Medical, LP
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2020
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Sep 23, 2020
Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RLC Labs Inc.
23 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 9, 2020
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
FDA (openFDA device enforcement)
Reported Sep 9, 2020
UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Santa Cruz Biotechnology, Inc.
FDA (openFDA drug enforcement)
Reported Sep 2, 2020
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Yusef Manufacturing Laboratories, LLC
FDA (openFDA drug enforcement)
Reported Aug 26, 2020
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc.,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Ferring Pharmaceuticals Inc.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 26, 2020
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2020
Asiaticon SA de CV recalls V-Klean, Medical Minded, Protz Hand Sanitizer due to Potential presence of methanol (wood alcohol) and subpotent ethanol levels
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Asiaticon SA de CV
FDA (recalls & safety alerts)
Reported Aug 19, 2020
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.PAI Holdings, LLC. dba Pharmaceutical Associates Inc.
FDA (openFDA drug enforcement)
Reported Aug 19, 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 Aug 12, 2020
Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Yusef Manufacturing Laboratories, LLC
FDA (openFDA drug enforcement)
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)
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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.