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 2769

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-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 Wilmo
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-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-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-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-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-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 (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 Distribution,
Category
Drug
Distribution
0 states
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, Ta
Category
Food
Distribution
1 state
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 (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-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; MPRESS
Category
Medical Device
Distribution
0 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 (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-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-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 (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 (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 1
Category
Drug
Distribution
Distributed nationwide
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-1162-2017·2017-09-20
Aidarex Recalls Phentermine Capsules Due to Impurity Test Failures
Aidarex Pharmaceuticals is recalling 35 bottles of Phentermine 15 mg capsules because they failed impurity specifications during stability testing.
Product
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Category
Drug
Distribution
2 states
LowFDA (Drugs)·D-1139-2017·2017-09-20
VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Labeling Error
VistaPharm, Inc. is recalling 3,084 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the product was incorrectly labeled as a Class III controlled substance instead of a Class II controlled substance.
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3128-2017·2017-09-20
Fujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection
Fujifilm is recalling 260 user manuals for the ED-530XT endoscope following an FDA inspection. The recall is a corrective action to address documentation issues.
Product
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other pur
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3132-2017·2017-09-20
Boston Scientific Recalls FFR Link Signal Processing Modules for Missing Test Records
Boston Scientific is recalling three FFR Link Signal Processing Modules because the device history record was missing documentation for final electrical testing.
Product
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they c
Category
Medical Device
Distribution
1 state