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.

4801–4825 of 21589

  • 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-0597-2022·2022-03-02

    Parents Choice Infant Acetaminophen Recalled for Contaminated Excipient

    Perrigo Company is recalling approximately 55,656 bottles of Parents Choice Infants Pain and Fever (Acetaminophen) oral suspension nationwide due to CGMP deviations. The product was manufactured with a contaminated excipient that was recalled from the supplier.

    Product
    PARENTS CHOICE INFANTS PAIN AND FEVER — PARENTS CHOICE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0572-2022·2022-03-02

    Prevantics Swabstick Chlorhexidine Recall Due to Test Validation Uncertainty

    Professional Disposables International is recalling Prevantics Swabstick (chlorhexidine gluconate and isopropyl alcohol) products nationwide due to uncertain validation of the test methods used during manufacturing.

    Product
    PREVANTICS SWABSTICK — PREVANTICS SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    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-0589-2022·2022-03-02

    Equate Children's Pain and Fever Acetaminophen Recalled for Contaminated Excipient

    Perrigo Company is recalling Equate Children's Pain and Fever acetaminophen suspension due to contamination from a recalled excipient used during manufacturing. The affected batch was distributed nationwide.

    Product
    EQUATE CHILDRENS PAIN AND FEVER — EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0620-2022·2022-03-02

    Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient

    Perrigo Company PLC is recalling NASAL Maximum Strength No Drip Nasal Spray (oxymetazoline HCl 0.05%) because the product was manufactured with a contaminated excipient from a recalled supplier.

    Product
    NASAL — NASAL (OXYMETAZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0678-2022·2022-03-02

    ImmunoCard STAT Rotavirus diagnostic tests recalled for improper storage temperature

    Meridian BioscienceImmunoCard STAT! Rotavirus tests were shipped at room temperature instead of refrigerated, which may affect their reliability.

    Product
    meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotaviru
    Category
    Medical Device
    Distribution
    7 states
  • 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-0573-2022·2022-03-02

    Methylphenidate Hydrochloride Chewable Tablets Recalled for Failed Specifications

    Rising Pharmaceuticals is voluntarily recalling Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, due to a tablet size defect. One tablet in a sealed bottle was found to be twice the size of other tablets in the same bottle.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0627-2022·2022-03-02

    DG Health Sinus Severe nasal decongestant recalled for contaminated excipient

    Perrigo Company is recalling DG Health Sinus Severe nasal decongestant because the product was manufactured with a contaminated excipient that was recalled from the supplier. Three batches are affected.

    Product
    DG HEALTH SINUS SEVERE — DG HEALTH SINUS SEVERE (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0640-2022·2022-03-02

    Sapropterin Dihydrochloride Powder Recall for Subpotent Drug

    Dr. Reddy's Laboratories is recalling Sapropterin Dihydrochloride Powder for Oral Solution (100 mg) nationwide due to out-of-specification assay results indicating the product contains less active ingredient than labeled.

    Product
    Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2022·2022-03-02

    Oxymetazoline Nasal Spray Recalled for Contaminated Excipient

    Perrigo Company is recalling Maximum Strength No Drip Nasal Spray containing oxymetazoline HCl because it was manufactured with a contaminated excipient obtained from a recalled supplier.

    Product
    NASAL — NASAL (OXYMETAZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0581-2022·2022-03-02

    Rugby Children's Acetaminophen Oral Suspension Recalled for Contaminated Excipient

    Perrigo Company PLC is recalling Rugby Children's Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that had been recalled from the supplier.

    Product
    RUGBY CHILDRENS ACETAMINOPHEN — RUGBY CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2022·2022-03-02

    Perrigo TopCare Nasal Spray Recalled for Contaminated Excipient

    TopCare Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) manufactured by Perrigo Company PLC is being recalled nationwide because the product was made with a contaminated excipient that was itself recalled by the supplier. Consumers should stop using affected batches.

    Product
    TOPCARE NASAL — TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0613-2022·2022-03-02

    Basic Care No Drip Nasal Spray Recalled for Contaminated Excipient

    Perrigo Company is recalling 1,296 bottles of Basic Care No Drip Nasal Spray (oxymetazoline hydrochloride 0.05%) distributed nationwide due to contaminated excipient used during manufacturing.

    Product
    BASIC CARE NO DRIP NASAL — BASIC CARE NO DRIP NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0609-2022·2022-03-02

    Signature Care Nasal Decongestant Recalled for Contaminated Excipient

    Perrigo Company PLC is recalling Signature Care Nasal Decongestant because the product was manufactured with a contaminated excipient that was itself recalled by its supplier. The recall affects approximately 14,784 bottles distributed nationwide.

    Product
    SIGNATURE CARE NASAL DECONGESTANT — SIGNATURE CARE NASAL DECONGESTANT (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-0584-2022·2022-03-02

    UP AND UP Acetaminophen Infant Suspension Recalled for Contaminated Excipient

    Perrigo Company PLC is recalling UP AND UP Acetaminophen Infant Dye Free Grape Oral Suspension due to use of a contaminated excipient supplied by an outside vendor. The product was distributed nationwide.

    Product
    UP AND UP ACETAMINOPHEN — UP AND UP ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0583-2022·2022-03-02

    Acetaminophen Child Strawberry Suspension Recalled for Contaminated Excipient

    Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) due to use of a contaminated excipient. The product was manufactured with a recalled ingredient from the excipient supplier.

    Product
    Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0606-2022·2022-03-02

    DG Health Nasal Spray Recalled for Contaminated Excipient

    Perrigo Company PLC is recalling DG Health Nasal Spray (Oxymetazoline HCl 0.05%) distributed nationwide because the product was manufactured with a contaminated excipient that was itself recalled from the supplier.

    Product
    DG HEALTH NASAL — DG HEALTH NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2022·2022-03-02

    DG Health Nasal Spray Recalled for Contaminated Excipient

    Perrigo Company is recalling DG Health Nasal (Oxymetazoline Hydrochloride) nasal spray because it was manufactured with a contaminated excipient obtained from a recalled supplier.

    Product
    DG HEALTH NASAL — DG HEALTH NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0565-2022·2022-02-23

    Alprazolam Tablets 0.5 mg Recalled Due to cGMP Deviations

    ANI Pharmaceuticals is voluntarily recalling Alprazolam Tablets USP 0.5 mg in multiple package sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 205,662 bottles distributed across the United States.

    Product
    Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0650-2022·2022-02-23

    Merete PediatrOS RigidTack surgical device recalled for incorrect size label

    Merete Medical recalled 26 units of Merete PediatrOS RigidTack (pediatric orthopedic implant, 20 mm) due to incorrect marketing label stating 25 mm. Distribution: Illinois and Germany.

    Product
    Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0645-2022·2022-02-23

    Howmedica Dall Miles SM GRIP surgical device recalled for potential package de-bonding

    Howmedica is recalling the Dall Miles SM GRIP device because the outer Tyvek protective package may separate from the sealed unit. The affected batch should be inspected before use.

    Product
    Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0566-2022·2022-02-23

    Alprazolam Tablets USP 1.0 mg Recalled for cGMP Deviations

    ANI Pharmaceuticals has recalled Alprazolam Tablets USP 1.0 mg distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 173,499 bottles across multiple lot numbers.

    Product
    Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
    Category
    Drug
    Distribution
    Distributed nationwide