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.

2701–2725 of 3531

  • ModerateFDA (Drugs)·D-0632-2022·2022-03-09

    Amlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations

    Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2022·2022-03-09

    LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification

    A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.

    Product
    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0703-2022·2022-03-09

    QC Control Sets for GBS Testing Recalled Due to Contamination

    Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.

    Product
    QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Gro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling

    BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·20V514000·2022-03-08

    2021 BMW X7 Recalled for Incorrect Tire Information Labels

    BMW is recalling 2021 X7 models for tire information labels with incorrect specifications. The labels may not match the actually installed tires, potentially causing drivers to select wrong tires.

    Product
    BMW — 2021 BMW X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0603-2022·2022-03-02

    Basic Care No Drip Nasal Spray Recalled for Contaminated Excipient

    Perrigo Company is recalling 37,104 bottles of Basic Care No Drip Nasal Spray (oxymetazoline hydrochloride 0.05%) nationwide due to contaminated excipient used during manufacturing. The affected batches were distributed to U.S. consumers.

    Product
    BASIC CARE NO DRIP NASAL — BASIC CARE NO DRIP NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0587-2022·2022-03-02

    Good Sense Acetaminophen Child Suspension Recalled Due to Contaminated Excipient

    Perrigo is recalling Good Sense Pain and Fever acetaminophen child oral suspension (160mg/5ml, 4 FL OZ bottles) nationwide because the product was manufactured with a contaminated excipient that was recalled by the supplier.

    Product
    GOOD SENSE PAIN AND FEVER — GOOD SENSE PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2022·2022-03-02

    Prevantics Swab Drug Recall for Test Method Validation Deficiency

    Professional Disposables International, Inc. is recalling Prevantics Swab (chlorhexidine gluconate and isopropyl alcohol) due to cGMP deviations involving inadequate validation of manufacturing test methods. The product was distributed nationwide in the USA and Puerto Rico.

    Product
    PREVANTICS SWAB — PREVANTICS SWAB (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0586-2022·2022-03-02

    Children's Acetaminophen Suspension Recalled for Manufacturing Defect

    Perrigo Company is recalling Children's Pain and Fever (Acetaminophen) oral suspension due to use of contaminated excipient during manufacturing. The product was distributed nationwide in the United States.

    Product
    CHILDRENS PAIN AND FEVER — CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0625-2022·2022-03-02

    TOPCARE NASAL Oxymetazoline HCl Recalled Due to Contaminated Excipient

    Perrigo Company PLC is recalling TOPCARE NASAL (Oxymetazoline HCl 0.05%) nasal spray nationwide because products were manufactured with a contaminated excipient obtained from a supplier whose material was recalled.

    Product
    TOPCARE NASAL — TOPCARE NASAL (OXYMETAZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2022·2022-03-02

    UP AND UP Children's Acetaminophen Oral Suspension Recalled for Contaminated Excipient

    Perrigo Company PLC is recalling UP AND UP Children's Acetaminophen Oral Suspension (160mg/5ml, 4 FL OZ bottles) because the product was manufactured with a contaminated excipient that was recalled by the supplier. The recall affects approximately 26,832 bottles distributed nationwide.

    Product
    UP AND UP CHILDRENS ACETAMINOPHEN — UP AND UP CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0596-2022·2022-03-02

    Infants Pain and Fever acetaminophen recalled for contaminated excipient

    Perrigo Company is recalling Infants Pain and Fever acetaminophen oral suspension (160mg/5ml) distributed nationwide due to contamination from a recalled excipient supplier. The product was manufactured with a contaminated ingredient that does not meet manufacturing standards.

    Product
    INFANTS PAIN AND FEVER — INFANTS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2022·2022-03-02

    Infants Pain and Fever Acetaminophen recalled for contaminated excipient

    Perrigo Company is recalling Infants Pain and Fever Acetaminophen Infant Dye Free Grape Oral Suspension due to contaminated excipient used in manufacturing. The recall affects 1,296 bottles distributed nationwide.

    Product
    INFANTS PAIN AND FEVER — INFANTS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0622-2022·2022-03-02

    Signature Care Nasal Decongestant Recalled Due to Contaminated Excipient

    Perrigo Company PLC is recalling Signature Care Nasal Decongestant (Oxymetazoline HCl 0.05%) nationwide due to contamination from a recalled excipient used in manufacturing.

    Product
    SIGNATURE CARE NASAL DECONGESTANT — SIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2022·2022-03-02

    Equate Pain and Fever children's acetaminophen oral suspension recalled

    Perrigo Company PLC is recalling Equate Pain and Fever children's acetaminophen oral suspension nationwide due to contaminated excipient used in manufacturing that was itself recalled from the supplier.

    Product
    EQUATE PAIN AND FEVER — EQUATE PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0576-2022·2022-03-02

    Azacitidine 100mg Intravenous/Subcutaneous Drug Recall

    Dr. Reddy's Laboratories is recalling Azacitidine 100mg vials distributed nationwide due to failed stability specifications. The recall affects six lots with expiration dates ranging from August 2023 to April 2024.

    Product
    AZACITIDINE — AZACITIDINE (AZACITIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0580-2022·2022-03-02

    Equate Children's Pain and Fever Acetaminophen Suspension Recall

    Perrigo Company is recalling Equate Children's Pain and Fever Acetaminophen Suspension (160mg/5ml) due to contaminated excipient used in manufacturing. Approximately 117,552 bottles distributed nationwide are affected.

    Product
    EQUATE CHILDRENS PAIN AND FEVER — EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2022·2022-03-02

    Perrigo Severe Congestion Nasal Spray recalled for contaminated excipient

    Perrigo Company is recalling Severe Congestion Nasal Spray, No Drip Plus Menthol because the product was manufactured with a contaminated excipient that was recalled from the supplier.

    Product
    Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2022·2022-03-02

    Soothing 12 Hour Nasal Decongestant Spray Recall Due to Contaminated Excipient

    Perrigo Company PLC is recalling Soothing 12 Hour Nasal Decongestant Spray nationwide because the product was manufactured with a contaminated excipient that was recalled from the supplier.

    Product
    Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0570-2022·2022-03-02

    Prevantics Maxi Swabstick Recall Due to Manufacturing Validation Issues

    Professional Disposables International is recalling Prevantics Maxi Swabstick (chlorhexidine gluconate and isopropyl alcohol) due to unvalidated test methods used during manufacturing. The company has not reported any illnesses or injuries.

    Product
    PREVANTICS MAXI SWABSTICK — PREVANTICS MAXI SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2022·2022-03-02

    UP AND UP Childrens Acetaminophen Recall Due to Contaminated Excipient

    Perrigo Company is recalling UP AND UP Childrens Acetaminophen oral suspension due to contamination from a recalled excipient used in manufacturing. The product was distributed nationwide.

    Product
    UP AND UP CHILDRENS ACETAMINOPHEN — UP AND UP CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2022·2022-03-02

    Good Sense Children's Pain and Fever acetaminophen oral suspension recall

    Perrigo is recalling Good Sense Children's Pain and Fever acetaminophen oral suspension (160 mg/5 ml) in 4 FL OZ bottles due to contaminated excipient used during manufacturing. The recalled batch 1CK0963 (expiration 12/31/2022) was distributed nationwide.

    Product
    GOOD SENSE CHILDRENS PAIN AND FEVER — GOOD SENSE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0607-2022·2022-03-02

    CareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient

    Perrigo Company PLC is recalling 3,192 bottles of CareOne Severe Congestion Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) distributed nationwide because the products were manufactured with a contaminated excipient that was itself recalled from the supplier.

    Product
    CAREONE SEVERE CONGESTION NASAL — CAREONE SEVERE CONGESTION NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0608-2022·2022-03-02

    Nasal Oxymetazoline Spray Recalled for Contaminated Excipient

    Perrigo Company is recalling approximately 9,888 bottles of NASAL Severe Congestion Nasal Spray due to contamination from a recalled excipient used during manufacturing. The product was distributed nationwide.

    Product
    NASAL — NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0628-2022·2022-03-02

    Nasal Spray Oxymetazoline HCl Recalled Due to Contaminated Excipient

    Perrigo Company PLC is recalling Nasal Maximum Strength Nasal Spray (Oxymetazoline HCl 0.05%) due to contamination from a recalled excipient used during manufacturing. Approximately 2,302 bottles were distributed nationwide.

    Product
    NASAL — NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide