The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

14326–14350 of 21645

  • ModerateFDA (Devices)·Z-2196-2016·2016-07-20

    Synthes Recalls 1.5mm Stardrive Screwdrivers for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 383 units of 1.5mm Stardrive Screwdrivers because their MR Safety information does not meet current ASTM standards.

    Product
    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1438-2016·2016-07-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 7,850 boxes of Daytrana (methylphenidate) transdermal patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2193-2016·2016-07-20

    Synthes Recalls Surgical Handles for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 29 surgical handles because their MR safety labels do not meet current ASTM standards.

    Product
    Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2201-2016·2016-07-20

    Arrow Recalls Femoral Arterial Catheterization Kits Due to Labeling Error

    Arrow International Inc is recalling 50 femoral arterial catheterization kits because some shipping cartons contained the wrong product model.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2157-2016·2016-07-20

    Synthes Recalls 4.5 mm Cannulated Screws Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 4.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2155-2016·2016-07-20

    Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1439-2016·2016-07-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 2,088 boxes of Daytrana transdermal patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·052-2016 EXP-2·2016-07-14

    U.S. Cado Holdings Recalls Imported Frozen Swai Fillets for Regulatory Non-Compliance

    U.S. Cado Holdings is recalling approximately 29,645 pounds of imported frozen Swai fillets that entered U.S. commerce without meeting federal residue testing requirements.

    Product
    U.S. Cado Holdings, Inc. Recalls Imported Siluriformes Fish Products Distributed Without Meeting FSIS Requirements
    Category
    Food
    Distribution
    9 states
  • ModerateUSDA FSIS·060-2016·2016-07-14

    Haring Catfish Recalls Catfish Products Due to Gentian Violet Residue

    Haring Catfish, Inc. is recalling approximately 21,521 pounds of catfish products found to contain gentian violet, a chemical residue of public health concern.

    Product
    Haring Catfish — Haring Catfish, Inc. Recalls Siluriformes Fish Products Due To Possible Adulteration
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1160-2016·2016-07-13

    Cantrell Drug Recalls Heparin Sodium Syringes Due to Stability Data Concerns

    Cantrell Drug Company is recalling 4,170 syringes of Heparin Sodium in 0.45% Sodium Chloride because stability data does not support the expiration date.

    Product
    HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1077-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Germall Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all Germall products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1067-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls 4-Aminopyridine Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all 4-aminopyridine products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1129-2016·2016-07-13

    Reliable Drug Recalls Compounded Hydroquinone Products Due to Processing Controls

    Reliable Drug is recalling all compounded hydroquinone products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

    Product
    All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1063-2016·2016-07-13

    Dr. Reddy's Recalls Sirolimus Tablets Due to Impurity

    Dr. Reddy's Laboratories is recalling specific lots of Sirolimus tablets because they failed impurity specifications for secorapamycin.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1135-2016·2016-07-13

    Reliable Drug Recalls Potassium Bromide Products Due to Processing Control Issues

    Reliable Drug is recalling all compounded potassium bromide products due to a lack of processing controls. The recall affects products distributed in California, Hawaii, and New Mexico.

    Product
    All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1073-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls All Progesterone Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all progesterone products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1127-2016·2016-07-13

    Reliable Drug Recalls Methyltestosterone Products Due to Processing Control Issues

    Reliable Drug is recalling all methyltestosterone products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1099-2016·2016-07-13

    Reliable Drug Recalls Naltrexone Products Due to Processing Control Issues

    Reliable Drug is recalling all naltrexone products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1115-2016·2016-07-13

    Reliable Drug Recalls Quinacrine Products Due to Processing Control Deficiencies

    Reliable Drug is recalling all compounded quinacrine products due to a lack of processing controls. The recall affects products distributed in California, Hawaii, and New Mexico.

    Product
    All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1076-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Betamethasone Dipropionate Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all betamethasone dipropionate products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1108-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Squaric Acid Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all squaric acid products due to a lack of processing controls. The recall covers lots compounded between March 2015 and March 2016.

    Product
    All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-1617-2016·2016-07-13

    Zarbee's Baby Omega 3 Liquid Supplement Recalled for Contaminants

    Zarbee's Naturals is recalling Baby Omega 3 liquid supplements because some units contain elevated aerobic plate counts and do not meet visual appearance standards.

    Product
    Baby Omega 3 Dietary supplement (in liquid form), 15 ml and 14 ml in glass bottle with dropper dispenser.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1134-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls All Baclofen Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all baclofen products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1080-2016·2016-07-13

    Reliable Drug Recalls Compounded Propylparaben Products Due to Processing Controls

    Reliable Drug is recalling all compounded propylparaben products due to a lack of processing controls. The recall affects products distributed in California, Hawaii, and New Mexico.

    Product
    All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1079-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Methimazole Products Due to Processing Controls

    Reliable Compounding Pharmacy is recalling all methimazole products compounded between March 2015 and March 2016 due to a lack of processing controls.

    Product
    All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states