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.

7001–7025 of 21595

  • ModerateFDA (Drugs)·D-1193-2020·2020-04-22

    FDA Recalls Bi-Est Cream Due to Lack of Processing Control

    The FDA is recalling Bi-Est/DHEA/Testosterone cream from The Medicine Shoppe Pharmacy in Florida due to a lack of processing control.

    Product
    Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1211-2020·2020-04-22

    Medicine Shoppe Pharmacy Recalls Hydrocortisone and Econazole Cream Tubes

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling specific tubes of Hydrocortisone 2.5%/Econazole 1% cream due to a lack of processing control.

    Product
    Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1201-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progest/DHEA cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1723-2020·2020-04-22

    Canon Aquilion Prime CT Scanner Recalled for System Shutdown Errors

    Canon Medical System is recalling 10 Aquilion Prime CT scanners because a software error may interrupt scanning and prevent normal shutdown, resulting in data loss.

    Product
    Canon Aquilion Prime, Model TSX-303A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1218-2020·2020-04-22

    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)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1209-2020·2020-04-22

    Estriol 5 mg Suppositories Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Estriol 5 mg Suppositories due to a lack of processing control. The affected lot is distributed in Florida.

    Product
    Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1719-2020·2020-04-22

    Canon Aquilion Lightning CT Scanner Recalled for System Shutdown Errors

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

    Product
    Canon Aquilion Lightning, Model TSX-036A
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-1213-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

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

    Product
    Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1237-2020·2020-04-22

    Aurobindo Recalls Oxycodone and Acetaminophen Tablets Due to Water Leakage

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

    Product
    OXYCODONE AND ACETAMINOPHEN — OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1182-2020·2020-04-22

    Estradiol Vaginal Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Estradiol Vaginal Cream 0.01% due to lack of processing control. Affected lots were distributed in Florida.

    Product
    Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1242-2020·2020-04-22

    Dermatone Sunscreen Recalled for Microbial Contamination

    Filltech USA is recalling Dermatone Sunscreen Lotion SPF 50 due to positive tests for yeast and bacteria.

    Product
    Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Be
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1192-2020·2020-04-22

    Bi-Est 1:1 Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progesterone/Testosterone cream due to lack of processing control.

    Product
    Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1194-2020·2020-04-22

    The Medicine Shoppe Pharmacy Recalls Hydroquinone Cream Due to Processing Control Issues

    The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid cream due to a lack of processing control.

    Product
    Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, 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
  • ModerateFDA (Drugs)·D-1205-2020·2020-04-22

    Paregoric Compound Solution Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy in Port Charlotte, FL, is recalling Paregoric Compound Solution due to a lack of processing control.

    Product
    Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1180-2020·2020-04-22

    Naltrexone Capsules Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Naltrexone 4.5 mg capsules due to a lack of processing control.

    Product
    Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1223-2020·2020-04-22

    Ketoprofen/DMSO Lipoderm Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jars due to lack of processing control.

    Product
    Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1702-2020·2020-04-22

    Merit Medical Recalls Nonsterile ChloraPrep Applicators for Vein Trays

    Merit Medical Systems is recalling six units of nonsterile ChloraPrep applicators that were inadvertently shipped to a customer in Illinois.

    Product
    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1188-2020·2020-04-22

    Bi-Est Cream Recalled by Florida Pharmacy for Lack of Processing Control

    The Medicine Shoppe Pharmacy in Port Charlotte, FL, is recalling Bi-Est cream due to a lack of processing control. The affected product is a prescription topical cream.

    Product
    Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1224-2020·2020-04-22

    Testosterone Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Testosterone Cream due to a lack of processing control. The product was distributed in Florida.

    Product
    Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1208-2020·2020-04-22

    Naltrexone Suspension Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Naltrexone 4.5 mg/mL Suspension due to lack of processing control. The product was distributed in Florida.

    Product
    Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • 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-1696-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm - 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 (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