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.

2751–2775 of 3531

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-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-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-0585-2022·2022-03-02
CVS Infant's Grape Acetaminophen Suspension Recalled for Contaminated Excipient
CVS Pharmacy is recalling Infant's Grape Flavored Acetaminophen Oral Suspension nationwide because the product was manufactured with a contaminated excipient that was recalled from its supplier.
Product
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16
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 (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-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-0599-2022·2022-03-02
Equate Children's Pain and Fever recalled due to contaminated excipient
Perrigo Company is recalling Equate Children's Pain and Fever (Acetaminophen) oral suspension nationwide due to manufacturing deviations involving contaminated excipient from a supplier.
Product
EQUATE CHILDRENS PAIN AND FEVER — EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
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-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-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-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-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-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-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-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-0646-2022·2022-03-02
Premium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol Content
Premium Nature Instant Hand Sanitizer is being recalled nationwide because some bottles were found to contain subpotent levels of ethanol. The FDA identified the issue during analysis of multiple bottle sizes.
Product
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0560-2022·2022-02-23
Moxifloxacin Ophthalmic Solution Recall for Failed Impurities Specifications
Aurobindo Pharma USA Inc. is recalling Moxifloxacin Ophthalmic Solution 0.5% due to failed impurities and degradation specifications. The recall affects 115,776 bottles distributed nationwide.
Product
MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0564-2022·2022-02-23
Alprazolam Tablets USP 0.25 mg Recalled for cGMP Deviations
ANI Pharmaceuticals is recalling Alprazolam Tablets USP 0.25 mg nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects multiple lot numbers of 100-count, 500-count, and 1000-count bottles distributed across the United States.
Product
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0567-2022·2022-02-23
Alprazolam Tablets 2.0 mg Recalled for cGMP Deviations
ANI Pharmaceuticals is recalling Alprazolam Tablets, USP 2.0 mg nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 70,788 bottles distributed throughout the United States.
Product
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0558-2022·2022-02-23
Diazepam Oral Solution Recalled for Failed Impurity Specifications
Lannett Company is recalling Diazepam Oral Solution (Concentrate) 5 mg/mL due to out-of-specification results for related substances, indicating failed impurities and degradation testing.
Product
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
Category
Drug
Distribution
Distributed nationwide
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
ModerateFDA (Drugs)·D-0716-2022·2022-02-23
Erythromycin Topical Gel Recalled for Failed Impurity Specifications
Teligent Pharma is recalling one lot of Erythromycin Topical Gel USP 2% because the product failed to meet specifications for unknown maximum related compounds.
Product
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
Category
Drug
Distribution
Distributed nationwide