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.

751–775 of 3531

  • ModerateFDA (Drugs)·D-0580-2024·2024-07-10

    Dodex Injectable Cyanocobalamin Recalled Due to Subpotent Drug Defect

    Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin) due to subpotency; affected batches contain less active ingredient than labeled. Patients using affected lots should contact their healthcare provider.

    Product
    Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0584-2024·2024-07-10

    Venlafaxine Extended-Release Capsules Recalled for Failed Dissolution

    The FDA is recalling Venlafaxine Hydrochloride extended-release capsules (37.5mg) distributed nationwide because routine stability testing revealed the capsules failed to meet dissolution specifications, potentially affecting drug effectiveness.

    Product
    Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0577-2024·2024-07-10

    Little Moon Essentials Asana Kisser Drug Recalled Due to CGMP Deviations

    Little Moon Essentials Asana Kisser, a topical product containing camphor and menthol, is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 320 units distributed in the United States and Canada.

    Product
    Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2245-2024·2024-07-10

    Medical Device Calibrator Kit Assigned Extended Incorrect Expiration Date

    Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.

    Product
    VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0573-2024·2024-07-10

    Drug Recall: Little Moon Essentials Aching Head Rub for Manufacturing Defects

    Little Moon Essentials Aching Head Rub is being recalled by the manufacturer for manufacturing deviations. The voluntary recall affects 6,312 units distributed nationwide and in Ontario, Canada.

    Product
    Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2260-2024·2024-07-10

    Stryker Curved Cement Delivery Needles Recalled: Expired Products Distributed

    Stryker recalled its Curved Cement Delivery Needle (Lot 6659783) due to expired product distribution. Three units were distributed to customers in Arkansas, California, Colorado, Florida, and Michigan.

    Product
    Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0566-2024·2024-07-03

    Extra Strength Acetaminophen 500mg Tablets Recalled for Discoloration

    Contract Pharmacal Corporation is recalling 14,616 bottles of Extra Strength Acetaminophen 500mg tablets due to discoloration appearing as brownish tablets. The affected lot was distributed in Michigan.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2223-2024·2024-07-03

    Cook Drainage Catheter Recall: Incorrect Expiration Date Labels

    Cook Incorporated is recalling 15 units of a multipurpose drainage catheter due to product labels stating incorrect expiration dates that extend beyond the devices' true expiration, creating a risk of expired device use.

    Product
    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GP
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2220-2024·2024-07-03

    CDC Influenza H5 Subtyping Kit may produce inconclusive test results

    The CDC Influenza A/H5 Subtyping Kit's H5b component may fail to amplify, resulting in inconclusive results. 191 units were distributed nationwide.

    Product
    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2024·2024-07-03

    Sonic Scaler Tip Holder May Be Oversized, Preventing Proper Seating

    The tip holder portion of Titan Blis-Sonic Scaler tips may be oversized, preventing proper seating in the scaler handpiece. This defect could result in the tip becoming loose during use.

    Product
    Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24286·2024-06-27

    Daikin, Amana, and Goodman Heat Pumps Recalled for Excessive Heat Risk

    Daikin Comfort Technologies is recalling about 56,000 Daikin FIT, Amana Brand S-series, and Goodman SD heat pumps due to a power interruption defect that can cause the units to provide heat even when the thermostat is set to cooling mode, posing a risk of excessive heat exposure.

    Product
    Daikin FIT, Amana Brand S-series, and Goodman SD heat pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2024·2024-06-26

    OPTETRAK One Peg Patella components recalled for out-of-specification vacuum bags

    Exactech is recalling OPTETRAK One Peg Patella knee implants due to vacuum bags packaged below specification. The recall affects units with multiple lot numbers distributed worldwide.

    Product
    OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0556-2024·2024-06-26

    Drug Recall: Eptifibatide Injection Due to Failed Degradation Specifications

    Eugia US LLC is recalling 15,500 vials of Eptifibatide injection nationwide due to failed impurities and degradation specifications. The defect involves a related substance identified as Eptifibatide dimer.

    Product
    EPTIFIBATIDE — EPTIFIBATIDE (EPTIFIBATIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution

    Wondfo USA recalls Areta Strep A test kits (Lot E03920802) distributed for unauthorized at-home and over-the-counter use. The recall affects 75,000 units distributed nationwide.

    Product
    Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0551-2024·2024-06-19

    ASMANEX Inhalation Powder Recalled Due to Defective Container

    Organon LLC is recalling 2,551 units of ASMANEX Twisthaler mometasone furoate inhalation powder nationwide due to defective containers. Affected lot X024051 expires April 25, 2025.

    Product
    ASMANEX — ASMANEX (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0552-2024·2024-06-19

    Asmanex Twisthaler inhalation powder recalled due to defective container

    Organon LLC is recalling Asmanex Twisthaler (mometasone furoate) inhalation powder nationwide due to defective containers. Affected lot #Y000085 expires April 25, 2025.

    Product
    Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2024·2024-06-19

    NEOMED Pharmacy Syringes recalled due to missing expiration dates

    Avanos Medical is recalling NEOMED Pharmacy Syringes because expiration dates were not printed on the outer shipping labels. Approximately 37,476 cases of various syringe sizes were distributed worldwide.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0550-2024·2024-06-19

    Asmanex (Mometasone Furoate) Recalled Due to Defective Container

    Organon LLC has voluntarily recalled 2,886 units of Asmanex inhalation powder nationwide due to defective containers.

    Product
    ASMANEX — ASMANEX (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2024·2024-06-19

    Medical device nerve block needles incorrectly labeled as DEHP-free

    Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.

    Product
    Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2036-2024·2024-06-19

    NEOMED nonsterile pharmacy syringes recalled for missing expiration dates on labels

    Avanos Medical recalls NEOMED nonsterile pharmacy syringes because expiration dates were not printed on outer shipping labels, resulting in expired products being distributed.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2024·2024-06-19

    Strep A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA is recalling approximately 1.2 million Preview Strep A rapid test kits (Part Numbers PRE-STA-25 and PRE-STA-A-10) that were distributed for at-home and direct-to-consumer use. The device is intended for professional channels only.

    Product
    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2024·2024-06-19

    Darby Dental Prophylaxis Paste Mislabeled with Incorrect Part Number

    Young Dental Manufacturing is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion (Lot 248607) due to incorrect part number labeling. The product was labeled as part number 045032 instead of the correct 040032.

    Product
    Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2024·2024-06-19

    NEOMED Oral Syringes Recalled Over Missing Expiration Dates on Labels

    Avanos Medical is recalling NEOMED oral syringes because expiration dates were not printed on outer shipping labels, allowing expired units to reach customers.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1284-2024·2024-06-12

    Charles Boggini Pink Lemonade Recalled for Undeclared Food Dye

    Charles Boggini Pink Lemonade in 1 and 5-gallon sizes is recalled for containing undeclared FD&C Red No. 40. The colorant was not listed on product labels.

    Product
    Charles Boggini Pink Lemonde; 1 or 5 U.S. Gallons
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0543-2024·2024-06-12

    Estradiol transdermal patches recalled for failed quality specifications

    Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide