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.

20951–20975 of 21633

  • ModerateFDA (Drugs)·D-074-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling 1.9 million Thyro-Tab tablets because they failed to meet in-process specification requirements.

    Product
    Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-081-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0742-2013·2012-12-12

    Blue Diamond Almond Breeze Almond Milk Recalled for Undeclared Cocoa

    HP Hood LLC is recalling Blue Diamond Almond Breeze Almond Milk because it may contain undeclared cocoa and evaporated cane juice.

    Product
    Blue Diamond Almond Breeze Almond milk Half Gallon (1.89 L) Paper Carton UPC: 4157005618
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-079-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements due to cGMP deviations.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-084-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.300 mg Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 1,902,957 Thyro-Tab 0.300 mg tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2013·2012-12-12

    Stryker Orthopaedics Recalls Mismarked Femoral Offset Bushing Instruments

    Stryker Howmedica Osteonics Corp. is recalling 7 units of non-sterile Femoral Offset Bushing Triathlon Revision Instruments due to incorrect or missing rotational markings.

    Product
    Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-078-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.8 million Thyro-Tab 0.112 mg tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0454-2013·2012-12-12

    Stryker Neptune 2 Rover Recall Due to Castor Binding Defect

    Stryker is recalling Neptune 2 Rover waste management systems because a castor design defect can cause the unit to bind, potentially leading to operator back pain.

    Product
    Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-085-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-073-2013·2012-12-12

    Ferring Recalls Novarel Injection Due to Missing Anaphylaxis Warning

    Ferring Pharmaceuticals is recalling Novarel (Chorionic Gonadotropin) vials because the package insert is missing a warning about anaphylaxis.

    Product
    Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC #…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0480-2013·2012-12-12

    Siemens Mobilette Mira Mobile X-ray System Recalled for Image Loss Risk

    Siemens Medical Solutions USA is recalling 21 Mobilette Mira mobile x-ray systems due to a risk of lost images during examination.

    Product
    Siemens Mobilette Mira, intended use as Mobile x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0470-2013·2012-12-12

    Stryker Tibial Offset Bushing Recall Due to Incorrect Markings

    Stryker Howmedica Osteonics is recalling 8 Tibial Offset Bushings because rotational reference numbers were marked incorrectly or missing.

    Product
    Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-086-2013·2012-12-12

    Taro Recalls Fluorouracil Topical Cream Due to Stability Issues

    Taro Pharmaceuticals is recalling Fluorouracil Topical Cream 5% because out-of-specification results were found in retain samples.

    Product
    FLUOROURACIL — FLUOROURACIL (FLUOROURACIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-082-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.7 million Thyro-Tab tablets because they do not meet in-process specification requirements and involve cGMP deviations.

    Product
    Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2013·2012-12-05

    GE Healthcare Recalls Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling Optima XR200amx and XR22Oamx mobile X-ray units due to a software issue on the interface.

    Product
    GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0442-2013·2012-12-05

    Biomet Echo Hip Stems Recalled Due to Incorrect Size Etching

    Biomet, Inc. is recalling four Echo Bi-Metric hip stems because the etching on the 11mm stems incorrectly indicated they were 13mm stems.

    Product
    Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0449-2013·2012-12-05

    GE Healthcare Recalls Mobile X-Ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the interface.

    Product
    GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-067-2013·2012-12-05

    Boehringer Ingelheim Recalls Pradaxa 75 mg Capsules Due to Defective Containers

    Boehringer Ingelheim is recalling 8,381 bottles of Pradaxa 75 mg capsules because defective containers may allow moisture to enter, potentially impairing product quality.

    Product
    Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2013·2012-12-05

    Metrex Research Recalls Pinnacle Cure Sleeves Due to Labeling Error

    Metrex Research is recalling Pinnacle Cure Sleeves because boxes labeled for 11mm light guides contain sleeves for 7mm or 8mm guides.

    Product
    Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-069-2013·2012-12-05

    Procter & Gamble Recalls Vicks NyQuil Due to Illegible Labeling

    Procter & Gamble is recalling 17,532 bottles of Vicks NyQuil Cold & Flu because portions of the dosing directions and warnings are obscured.

    Product
    Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0451-2013·2012-12-05

    Kimberly-Clark Patient Warming System Model 1000 Recalled for False Alarms

    Kimberly-Clark is recalling 400 Model 1000 Patient Warming System Control Units because the Error 85 alarm occasionally triggered inappropriately.

    Product
    Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0446-2013·2012-12-05

    Iradimed Recalls MRidium Series 1000 MR Infusion Sets Due to Specification Defect

    Iradimed Corporation is recalling 719 MRidium Series 1000 MR Infusion Sets because a section of the device does not meet specifications.

    Product
    The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0448-2013·2012-12-05

    GE Healthcare Recalls Mobile X-ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the product interface.

    Product
    GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE…
    Category
    Medical Device
    Distribution
    Distributed nationwide