Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1176–1200 of 2741

LowFDA (Food)·F-0126-2018·2017-11-15
San Gennaro White Polenta Recalled for Unapproved Ink Contact
San Gennaro Foods is recalling White Polenta because date coding ink was printed directly on the food contact surface, allowing the unapproved ink to touch the product.
Product
White Polenta, San Gennaro brand, 12/16oz packages, UPC# 7-62676-17400-2 White Polenta, San Gennaro brand, 6/16oz packages UPC# 7-62676-17400-2 Ingredients: Water, White Corn Meal, Salt, Tartaric Acid
Category
Food
Distribution
18 states
LowFDA (Drugs)·D-0072-2018·2017-11-15
Doan's Pain Relieving Cream Recalled for Packaging Labeling Mismatch
Dr. Reddy's is recalling Doan's Pain Relieving Cream because the lot number on the outer packaging does not match the bottle. This is a Class III labeling recall.
Product
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0130-2018·2017-11-15
San Gennaro Foods Recalls Frieda's Variety Pack Due to Ink Contact
San Gennaro Foods is recalling Frieda's Variety Pack pasta sauces because date coding ink was printed on the food contact surface of the packaging.
Product
Variety Pack Organic, Pre-cooked just heat & serve, 12/16oz packages, UPC# 0-37842-04159-5 Includes 3 retail units each of Frieda's brand: Sun-Dried Tomato & Garlic, Basil & Garlic, Green Chili & Cilantro, Mushroom & Onion
Category
Food
Distribution
18 states
LowFDA (Drugs)·D-0056-2018·2017-11-08
Sanofi Recalls Clofarabine Injection Vials Due to Incorrect Package Insert
Sanofi-Aventis is recalling 422 vials of Clofarabine injection because the authorized generic product was packaged with the incorrect package insert for the brand name product.
Product
Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0033-2018·2017-11-01
AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse
AbbVie is recalling specific lots of AndroGel testosterone gel because prolonged exposure to temperatures outside labeled storage conditions may have affected the product.
Product
AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0034-2018·2017-11-01
AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse
AbbVie is recalling 48 cartons of AndroGel testosterone gel distributed in Arizona due to prolonged exposure to temperatures outside labeled storage conditions.
Product
AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0051-2018·2017-11-01
Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures
Wockhardt USA is recalling 5mg Enalapril Maleate tablets because they failed impurity specifications. The recall covers 5,050 bottles distributed nationwide.
Product
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0052-2018·2017-11-01
Teva Recalls Methylphenidate Hydrochloride Tablets Due to Dissolution Failures
Teva Pharmaceuticals USA is recalling 58,292 bottles of Methylphenidate Hydrochloride Tablets USP, 20 mg, because they failed to meet dissolution specifications.
Product
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0073-2018·2017-11-01
Vi-Jon Recalls Equate and Studio 35 Face Moisturizers for Stability Failures
Vi-Jon, Inc. is recalling Equate and Studio 35 Clarifying Face Daily Moisturizers because the products failed stability specifications. The recall covers 67,532 bottles distributed nationwide.
Product
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0146-2018·2017-11-01
Taro Recalls Fluocinonide Gel Due to Dapsone Cross-Contamination
Taro Pharmaceuticals is recalling 16,944 tubes of Fluocinonide Gel USP 0.05% because traces of Dapsone were found in the finished product.
Product
FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0009-2018·2017-10-18
Dr. Reddy's Recalls Famotidine Tablets Due to Impurity Failure
Dr. Reddy's is recalling specific lots of famotidine tablets sold as CVS Pharmacy Acid Controller and Equate Famotidine due to an out-of-specification impurity result.
Product
FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0007-2018·2017-10-18
Mobic Tablets Recalled for Incorrect Package Insert Labeling
Boehringer Ingelheim is recalling 128 bottles of Mobic 15 mg tablets because they were packaged with an incorrect insert.
Product
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
Category
Drug
Distribution
2 states
LowFDA (Drugs)·D-0006-2018·2017-10-11
Vi-Jon Recalls Magnesium Citrate Oral Solution for Impurity Failures
Vi-Jon, Inc. is recalling 87,972 bottles of Magnesium Citrate Oral Solution because the product failed impurities and degradation specifications.
Product
Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer…
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0001-2018·2017-10-11
Pfizer Recalls Deferoxamine Mesylate Injection Due to CGMP Deviations
Pfizer is recalling 32,276 vials of Deferoxamine Mesylate for injection due to a failure to control impurities causing color change at the API stage.
Product
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0006-2018·2017-10-11
Quickie Stores Recalls Tofustrami Sandwiches for Undeclared Wheat
Quickie Stores, Inc. is recalling Tofustrami tofu sandwiches due to undeclared wheat. The recall affects 50 packages sold in Washington.
Product
Tofustrami sofu sandwich, plum bistro 2go brand, packaged in a transparent plastic clamshell container, sold at 10 oz. or 12 oz. UPC 8 64801 00010 8. The label is read in parts: "***TOFUSTRAMI tofu sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way…
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-3208-2017·2017-10-04
Zimmer Dental Recalls Impression Caps Due to Missing Supplemental Instructions
Zimmer Biomet is conducting a field correction for dental impression caps because they were shipped without supplemental instructions for use.
Product
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S…
Category
Medical Device
Distribution
0 states
LowFDA (Food)·F-3582-2017·2017-10-04
Lipari Foods Recalls Honey Roasted Sunflower Seeds for Off Taste
Lipari Foods is voluntarily recalling Honey Roasted Sunflower Seeds due to an off taste and mislabeled shelf life.
Product
Sunflower Seeds Honey Roasted, 12oz Tubs & 25lb Bulk
Category
Food
Distribution
9 states
LowFDA (Devices)·Z-3205-2017·2017-10-04
Zimmer Dental Thread Retrieval Drill Recall Due to Missing Supplemental Instructions
Zimmer Biomet is recalling Thread Retrieval Drills because they were shipped without supplemental instructions for use.
Product
THREAD RETRIEVAL DRILL REF 2224
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-1179-2017·2017-10-04
Sandoz Recalls Ampicillin Vials Due to Missing Labels
Sandoz Inc is recalling 13,435 packs of Ampicillin for Injection because some vials are missing labels. The recall covers distribution in the USA and Puerto Rico.
Product
AMPICILLIN — AMPICILLIN (AMPICILLIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3204-2017·2017-10-04
Zimmer Dental Guide Sleeves Recalled for Missing Supplemental Instructions
Zimmer Biomet is recalling specific dental guide sleeves because they were shipped with only standard instructions, missing required supplemental instructions.
Product
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-3207-2017·2017-10-04
Zimmer Dental Recalls Try-In Abutments Due to Missing Supplemental Instructions
Zimmer Biomet is recalling specific dental try-in abutments because they were shipped with standard instructions but lacked required supplemental instructions.
Product
TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-3210-2017·2017-10-04
Zimmer Dental Recalls Implants Due to Missing Supplemental Instructions
Zimmer Biomet is recalling 169 dental implants because they were shipped without supplemental instructions for use.
Product
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-3206-2017·2017-10-04
Zimmer Dental Recalls Abutment and Coping Products for Missing Instructions
Zimmer Biomet is correcting dental abutments and copings because they were shipped with standard instructions but missing supplemental instructions.
Product
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-1163-2017·2017-09-27
Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failures
Pfizer is recalling 14,712 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.
Product
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1164-2017·2017-09-27
Pfizer Recalls Quillivant XR Methylphenidate Suspension Due to Dissolution Failure
Pfizer is recalling 11,790 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.
Product
Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY…
Category
Drug
Distribution
Distributed nationwide