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.

4451–4475 of 21589

  • ModerateFDA (Drugs)·D-0999-2022·2022-06-15

    Bupivacaine Injectable Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection vials (NDC 55150-0170-30) distributed nationwide due to temperature abuse during manufacturing that may affect product quality. No illnesses have been reported.

    Product
    Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1069-2022·2022-06-15

    Medroxyprogesterone acetate injection recalled due to temperature abuse manufacturing deviation

    McKesson Medical-Surgical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) due to temperature abuse during manufacturing. The affected vials were distributed nationwide; patients should contact their healthcare provider.

    Product
    Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1093-2022·2022-06-15

    FDA Recalls Prazosin Hydrochloride Capsules Due to Temperature Storage Deviations

    McKesson is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide due to temperature deviations during storage that may affect medication stability.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0995-2022·2022-06-15

    FDA Class II Drug Recall: TOBRADEX Ophthalmic Ointment, Temperature Abuse

    McKesson Medical-Surgical is recalling TOBRADEX ophthalmic ointment nationwide due to cGMP deviations involving temperature abuse. Product distributed between June 1 and September 30, 2021 may be affected.

    Product
    TOBRADEX — TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1235-2022·2022-06-15

    Biliary Electrohydraulic Lithotripter Probe Recalled for Incorrect Product Labeling

    Northgate Technologies is recalling 55 AUTOLITH Touch 1.9F biliary lithotripter probes due to incorrect product labeling. Affected devices were distributed nationwide in Massachusetts.

    Product
    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1271-2022·2022-06-15

    Detox drink recalled for undeclared preservatives and food coloring

    Zydot Ultimate Blend The Original Detox Drink is recalled for undeclared preservatives (potassium sorbate, sodium benzoate) and food coloring R40. The recall involves 1,150 bottles distributed in the USA.

    Product
    Zydot Ultimate Blend The Original Detox Drink Natural Cherry Flavor 16 fl. oz. (473 ml) UPC 754515281439 packaged in plastic bottle with lid
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1021-2022·2022-06-15

    Ipratropium Bromide and Albuterol Sulfate inhalation solution recalled for temperature abuse

    McKesson Medical-Surgical has recalled Ipratropium Bromide and Albuterol Sulfate inhalation solution due to temperature abuse during storage that resulted in cGMP deviations. The nationwide recall affects 56 pouches; no illnesses or injuries have been reported.

    Product
    IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1077-2022·2022-06-15

    Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.

    Product
    Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0985-2022·2022-06-15

    Xiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications

    Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 0242
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0983-2022·2022-06-15

    Xiidra ophthalmic solution recalled for failed impurity and degradation specifications

    Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1075-2022·2022-06-15

    FDA Recalls Mupirocin Ointment Due to Temperature Control Deviations

    Mupirocin Ointment distributed nationwide is being recalled due to temperature abuse violations during manufacturing. Consumers with affected supplies should contact their pharmacy or healthcare provider for guidance.

    Product
    MUPIROCIN — MUPIROCIN (MUPIROCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1274-2022·2022-06-15

    Food bars potentially contaminated with insect filth recalled in Florida

    GRUVIPA S.L. is recalling CB1101001 BARRA XXL bars distributed in Florida due to potential contamination with insect filth. Consumers with affected lot codes should discard the product.

    Product
    CB1101001 BARRA XXL
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1078-2022·2022-06-15

    Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacture

    McKesson Medical-Surgical is recalling Teva Propofol Injectable Emulsion (200 mg/20 mL, 25-vial cartons) nationwide due to temperature abuse during manufacturing that may affect product quality. A total of 564 cartons were distributed.

    Product
    Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2022·2022-06-15

    JOBST Compri2 Compression Bandages Recalled for Folding Box Mislabeling

    BSN Medical Inc is recalling JOBST Compri2 and Compri2 lite compression bandages because the folding boxes containing the products are mislabeled. The actual products and immediate packaging are correctly labeled.

    Product
    (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0988-2022·2022-06-15

    FDA Recalls Teva Alprostadil Injection for Failed Impurity Specifications

    Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP due to out-of-specification results for impurities identified during routine stability testing. This FDA Class III recall affects 3,109 cartons distributed nationwide.

    Product
    Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0982-2022·2022-06-15

    Ophthalmic Drug Xiidra Recalled for Failed Impurity Specifications

    Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.

    Product
    XIIDRA — XIIDRA (LIFITEGRAST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1236-2022·2022-06-15

    1.8mm Truss Wire Component Recalled for Product Upgrade

    New Standard Device Inc is recalling 1.8mm truss wires used in the Metalogix Revolution External Plating System to facilitate introduction of stronger 2.0mm wires.

    Product
    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1068-2022·2022-06-15

    Prescription Lidocaine Patches Recalled for Temperature-Related Quality Deviations

    Mckesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during distribution that may affect product quality and efficacy. Affected patches were distributed nationwide.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1097-2022·2022-06-15

    Depo-Medrol injectable suspension recalled for manufacturing temperature control deviations

    McKesson Medical-Surgical is recalling Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension due to manufacturing temperature control deviations. The recall affects 177 cartons distributed nationwide.

    Product
    DEPO-MEDROL — DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1048-2022·2022-06-15

    FDA Recalls Metronidazole Vaginal Gel Due to Manufacturing Temperature Abuse

    The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.

    Product
    Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1001-2022·2022-06-15

    Bupivacaine HCl Injection Recalled for Temperature Control Deviation

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50
    Category
    Drug
    Distribution
    Distributed nationwide