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.

4776–4800 of 21589

ModerateFDA (Drugs)·D-0593-2022·2022-03-02
Acetaminophen Child Strawberry Oral Suspension Recalled for Contaminated Excipient
Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) nationwide due to manufacturing with a contaminated excipient that was itself recalled by the supplier.
Product
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0656-2022·2022-03-02
Medline Michels Transport Medium Recalled for Improper Storage Conditions
Medline is recalling 2,816 Michels Transport Medium prefilled containers due to improper storage in a temperature-controlled setting instead of refrigeration.
Product
Michels Transport Medium, 20ML Prefilled Cont
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0574-2022·2022-03-02
Pharmasol Lung Cleaner Saline Eucalyptus Inhaler Recall
Pharmasol Corporation is recalling Lung Cleaner (saline eucalyptus) inhalers in 37 oz cans due to current good manufacturing practice (cGMP) deviations identified during production.
Product
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0582-2022·2022-03-02
Children's Cherry Acetaminophen Oral Suspension Recalled for Contaminated Excipient
Perrigo is recalling Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that was recalled from the supplier.
Product
Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0577-2022·2022-03-02
Bortezomib 3.5 mg Vials Recalled Due to Failed Stability Specifications
Dr. Reddy's Laboratories is recalling Bortezomib 3.5 mg single-dose vials nationwide due to failed stability specifications. Approximately 2,980 vials of lot H210233 (expiration 3/1/2023) are affected.
Product
Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0610-2022·2022-03-02
Equaline Nasal Spray Recalled for Contaminated Excipient
Perrigo Company is recalling Equaline Nasal Spray (oxymetazoline HCl 0.05%) due to manufacturing with a contaminated excipient obtained from a recalled supplier. The recall affects approximately 2,664 bottles distributed nationwide.
Product
EQUALINE NASAL — EQUALINE NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0621-2022·2022-03-02
Perrigo Nasal Spray Recalled for Contaminated Excipient
Perrigo Company PLC is recalling approximately 15,264 bottles of NASAL Maximum Strength No Drip 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
NASAL — NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0647-2022·2022-03-02
Premium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol
AMS Packaging Inc is recalling Premium Nature Instant Hand Sanitizer (70% ethyl alcohol) in 8 oz and 16 oz bottles because some bottles contain less ethanol than labeled, reducing effectiveness.
Product
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0615-2022·2022-03-02
Nasal Mist Oxymetazoline HCl Recalled for Contaminated Excipient
Perrigo Company PLC is recalling approximately 64,512 bottles of NASAL MIST oxymetazoline nasal decongestant distributed nationwide because they were manufactured with a contaminated excipient recalled from the supplier.
Product
NASAL MIST — NASAL MIST (OXYMETAZOLINE HCL)
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-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-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-0626-2022·2022-03-02
Equate Nasal Spray Recalled for Contaminated Excipient Manufacturing Defect
Perrigo Company PLC is recalling Equate Nasal No Drip Nasal Spray because the product was manufactured with a contaminated excipient that was previously recalled from the supplier.
Product
EQUATE NASAL — EQUATE NASAL (OXYMETAZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0600-2022·2022-03-02
Children's Acetaminophen Oral Suspension Recalled for Contaminated Excipient
Perrigo Company is recalling 561 bottles of Children's Pain & Fever Acetaminophen 160 mg per 5 mL oral suspension due to contamination from a recalled excipient ingredient used during manufacturing.
Product
Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9
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-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-0611-2022·2022-03-02
Target Severe Congestion Nasal Spray recalled for contaminated excipient
Perrigo Company is recalling Target Severe Congestion Nasal Spray (Oxymetazoline HCl 0.05%) because it was manufactured with a contaminated excipient that had been recalled from the supplier.
Product
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10
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-0590-2022·2022-03-02
DG Health Children's Acetaminophen Recalled for Contaminated Excipient
Perrigo Company is recalling DG Health Children's Pain and Fever (acetaminophen) oral suspension because the product was manufactured with a contaminated excipient that was itself recalled by its supplier.
Product
DG HEALTH CHILDRENS PAIN AND FEVER — DG HEALTH CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0619-2022·2022-03-02
Perrigo Nasal Oxymetazoline Spray Recalled for Contaminated Excipient
Perrigo Company PLC is recalling approximately 10,800 bottles of NASAL Maximum Strength No Drip Nasal Spray (Oxymetazoline HCl 0.05%) nationwide due to manufacturing with a contaminated excipient supplied by their ingredient vendor.
Product
NASAL — NASAL (OXYMETAZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0579-2022·2022-03-02
Acetaminophen Oral Suspension Recalled for Contaminated Excipient
Perrigo is recalling Acetaminophen Oral Suspension Grape Flavor (160 mg/5 mL, 16 fl oz bottles) nationwide because the product was manufactured with a contaminated excipient that was recalled by the excipient supplier.
Product
Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43
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-0605-2022·2022-03-02
CareOne Severe Congestion Nasal Spray Recalled for Contaminated Excipient
Perrigo Company is recalling CareOne Severe Congestion Nasal Spray due to contaminated excipient used during manufacturing. The nasal spray was made with an excipient that had been recalled from the supplier.
Product
CAREONE SEVERE CONGESTION NASAL — CAREONE SEVERE CONGESTION NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0617-2022·2022-03-02
Nasal Decongestant Spray Recalled for Contaminated Excipient
Perrigo Company is recalling NASAL oxymetazoline HCl nasal spray nationwide due to contaminated excipient used in manufacturing. The affected product was distributed to retailers including Kroger.
Product
NASAL — NASAL (OXYMETAZOLINE HCL)
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