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.

7051–7075 of 21595

  • ModerateFDA (Devices)·Z-1697-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 40 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error

    Life Technologies is recalling 66 units of the Oncomine Dx Target Test RNA Control because the expiration date was extended prior to regulatory clearance.

    Product
    Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1722-2020·2020-04-22

    Canon Aquilion One Vision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion One Vision CT scanner because a software error can interrupt scans and cause loss of raw data.

    Product
    Canon Aquilion One Vision, Model TSX-301C
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1225-2020·2020-04-22

    Tretinoin Cream Recalled by Florida Pharmacy Due to Processing Control Issues

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Tretinoin 0.1% in Versabase Cream due to a lack of processing control.

    Product
    Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1206-2020·2020-04-22

    Hydromorphone Oral Solution Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Hydromorphone Oral 1 mg/mL Solution due to lack of processing control. The product was distributed in Florida.

    Product
    Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1187-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1220-2020·2020-04-22

    Paregoric Alternate Elixir Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Paregoric Alternate Elixir due to a lack of processing control.

    Product
    Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1714-2020·2020-04-22

    Greiner Bio-One Recalls VACUETTE Coagulation Tubes Due to Anticoagulant Inconsistency

    Greiner Bio-One is recalling VACUETTE 2mL 9NC Coagulation Tubes because the sodium citrate anticoagulant levels were inconsistent. The recall affects 1,000,800 units distributed nationwide.

    Product
    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1231-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1184-2020·2020-04-22

    Testosterone Gel Recalled by Florida Pharmacy for Lack of Processing Control

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling specific lots of Testosterone w/ Atrevis 100 mg/mL Gel due to a lack of processing control.

    Product
    Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1726-2020·2020-04-22

    Canon Aquilion One CT Scanner Recall for System Interruption

    Canon Medical System is recalling 35 Aquilion One CT scanners because a software error may interrupt scanning and prevent normal shutdown, causing loss of raw data.

    Product
    Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1210-2020·2020-04-22

    Hydrocortisone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream due to a lack of processing control.

    Product
    Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1196-2020·2020-04-22

    Diethylstilbestrol Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Diethylstilbestrol 1 mg capsules due to a lack of processing control. The recall is limited to Florida.

    Product
    Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1183-2020·2020-04-22

    Testosterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Testosterone w/ Atrevis 20 mg (2%) Cream due to lack of processing control.

    Product
    Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1725-2020·2020-04-22

    Canon Aquilion Precision CT Scanner Recalled for Data Loss Risk

    Canon Medical System is recalling one Aquilion Precision CT scanner because a software error may interrupt scanning and cause loss of raw data.

    Product
    Canon Aquilion Precision, Model TSX-304A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1219-2020·2020-04-22

    FDA Recalls Estriol/Testosterone Vaginal Cream Due to Processing Control Issues

    The FDA is recalling Estriol/Testosterone Vaginal 0.1/0.1% Cream from The Medicine Shoppe Pharmacy in Florida due to a lack of processing control.

    Product
    Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1216-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est cream due to a lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1227-2020·2020-04-22

    Betahistine 16 mg Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Betahistine 16 mg capsules due to lack of processing control. The recall affects 2 bottles distributed in Florida.

    Product
    Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1195-2020·2020-04-22

    Ergotamine Tartrate Suppositories Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Ergotamine Tartrate and Caffeine suppositories due to a lack of processing control.

    Product
    Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1226-2020·2020-04-22

    Ergotamine Tartrate and Caffeine Suppositories Recalled for Processing Control Issues

    The Medicine Shoppe Pharmacy is recalling Ergotamine Tartrate and Caffeine suppositories in Florida due to a lack of processing control.

    Product
    Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state