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.

13626–13650 of 21617

  • ModerateFDA (Drugs)·D-0129-2017·2016-11-16

    Wells Pharmacy Recalls Testosterone Pellets Due to Potency Issues

    Wells Pharmacy Network is recalling Testosterone 12.5 mg Pellets because they were found to be superpotent or subpotent.

    Product
    Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0344-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Pro Series 40 Due to Spoilage

    H.P. Hood is recalling Muscle Milk Pro Series 40 protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk Pro Series 40, 14 oz.. 40 g protein; Knock Out Chocolate UPC (case): 8-76063-00290-5; UPC (unit): 8-76063-00280-6
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0286-2017·2016-11-16

    Koffee Kup Bakery Recalls Plain Sandwich Rolls Due to Plastic Pieces

    Koffee Kup Bakery is recalling plain sandwich rolls because they may contain plastic pieces. Consumers should check their pantries and stop eating the product.

    Product
    Koffee Kup Sandwich Rolls- Plain, packaged 17 oz and 27 oz
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0283-2017·2016-11-16

    Koffee Kup Bakery Recalls Kaiser Rolls Due to Plastic Contamination

    Koffee Kup Bakery Inc. is recalling various Kaiser Rolls because they may contain pieces of plastic. Consumers in 11 states and D.C. should stop using the product.

    Product
    Koffee Kup Kaiser Rolls: Egg, Plain, Corn, White, Wheat, Sesame, Seeded Poppy packaged 12, and 15 oz
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0379-2017·2016-11-16

    Abbott Recalls Architect Lactic Acid Assay Due to Drug Interference

    Abbott is recalling 26,837 kits of the ARCHITECT Lactic Acid assay because the drug N-Acetyl Cysteine causes negative interference with the reagent.

    Product
    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0343-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Pro Series 40 Protein Shakes for Spoilage

    H.P. Hood is recalling Muscle Milk Pro Series 40 protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk Pro Series 40 14 oz;, 40 g protein Crushin' Cookies. UPC (case): 8-76063-00293-6; UPC (unit): 8-76063-00283-7
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0132-2017·2016-11-16

    Wells Pharmacy Recalls Estradiol Pellets Due to Potency Issues

    Wells Pharmacy Network is recalling Estradiol 12.5 mg Pellets because they may be superpotent or subpotent. Consumers should stop using the product.

    Product
    Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0355-2017·2016-11-16

    Island Biscuit Strawberry Snacks Recalled for Undeclared Food Dyes

    Lee'S Food Corp is recalling Island Biscuit "Yum Yum - Creamy Strawberry" snacks because sampling revealed undeclared food dyes.

    Product
    Island Biscuit "Yum Yum - Creamy Strawberry" Biscuit Snack, Net Wt. 30 g, UPC 4 800098 122952
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0337-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling Muscle Milk protein shakes in Cookies N Crème flavor due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 14 oz, 25 g protein Cookies N Cr¿me. UPC (case): 8-76063-00224-0; UPC (unit): 8-76063-00204-2
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0364-2017·2016-11-16

    FDA Adds Instructions for Use to Covidien Devon Light Glove Recall

    The FDA is adding instructions to inspect the barrier integrity of the Covidien Devon Light Glove after application. This affects sterile surgical kits distributed in the US and abroad.

    Product
    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0372-2017·2016-11-16

    Schaerer Surgical Table Floor Locking Cylinders Recalled for Leak Risk

    Schaerer Medical USA Inc is recalling replacement floor locking cylinders for model 7300 surgical tables because they may leak due to an incorrect O-ring.

    Product
    Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2017·2016-11-16

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Mislabeled French Size

    Stryker Sustainability Solutions is recalling four reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters because they may be mislabeled for French size during reprocessing.

    Product
    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0369-2017·2016-11-16

    Medimaps TBS iNsight Software Recalled for Incorrect FRAX Calculations

    Medimaps Group is recalling TBS iNsight v.3.0.1 software because FRAX values are incorrect when specific spine scan conditions are met.

    Product
    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0331-2017·2016-11-16

    H.P. Hood Recalls FitPro Go! Chocolate Chip Cookies Due to Spoilage

    H.P. Hood is recalling FitPro Go! 35 g protein Chocolate Chip Cookies because some containers showed signs of premature spoilage, including swelling and foul odor.

    Product
    FitPro Go! 14oz, 35 g protein Chocolate Chip Cookies UPC(Case): 8-5418200338-6; UPC Unit: 8-5418200325-6
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0330-2017·2016-11-16

    H.P. Hood Recalls FitPro Go! Chocolate Protein Bars Due to Spoilage

    H.P. Hood is recalling FitPro Go! 14oz Chocolate protein bars due to premature spoilage, including swelled containers and foul odor.

    Product
    FitPro Go! 14oz Chocolate; 35 g protein UPC Case: 8-5418200328-7; UPC Unit: 8-5418200324-9
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0345-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Pro Series 40 Due to Spoilage

    H.P. Hood is recalling Muscle Milk Pro Series 40 protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk Pro Series 40 14 oz., 40 g protein; Going Bananas UPC (case): 8-76063-00294-3; UPC (unit): 8-76063-00284-4
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0338-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling specific lots of Muscle Milk protein shakes because they may have spoiled prematurely, resulting in swelled containers and foul odors.

    Product
    Muscle Milk 14 oz., 25 g protein Strawberry; UPC (case): 8-76063-00229-5; UPC (unit): 8-76063-00209-7
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0340-2017·2016-11-16

    H.P. Hood Recalls Muscle Milk Protein Shakes Due to Spoilage

    H.P. Hood is recalling Muscle Milk Caramel Kick protein shakes due to premature spoilage, including swelled containers and foul odor.

    Product
    Muscle Milk 14 oz. 25 g protein Caramel Kick UPC (case): 8-76063-00214-1; UPC (unit): 8-76063-00219-6
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0371-2017·2016-11-16

    Schaerer 7300 Surgical Tables Recalled for Defective Floor Locking Cylinders

    Schaerer Medical USA Inc is recalling four 7300 model surgical tables because defective floor locking cylinders may leak due to incorrect O-rings.

    Product
    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0292-2017·2016-11-16

    Koffee Kup Bakery Recalls Plain Bulkie Rolls Due to Plastic Contamination

    Koffee Kup Bakery is recalling Big Y Plain Bulkie Rolls because they may contain plastic pieces. Consumers should check use-by dates and stop eating the product.

    Product
    Big Y Plain Bulkie Rolls-white packaged 15 oz and 17 oz
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-0124-2017·2016-11-09

    Akorn Recalls Subpotent Sodium Chloride Ophthalmic Solution

    Akorn Inc. is recalling 29,972 bottles of 5% Sodium Chloride Ophthalmic Solution because the product concentration is less than the labeled amount.

    Product
    Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1.5/30 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers specific lots distributed nationwide and in Puerto Rico.

    Product
    Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
    Category
    Drug
    Distribution
    Distributed nationwide