Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4401–4425 of 5062

LowFDA (Drugs)·D-0380-2022·2022-01-26
Rite Aid Allergy & Congestion Tablets Fail Dissolution Specifications
Rite Aid Pharmacy is recalling Allergy & Congestion extended-release tablets because two lots failed to meet dissolution specifications. The affected product was distributed nationwide.
Product
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0378-2022·2022-01-26
Wal-Fex D Allergy and Decongestant Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Wal-Fex D Extended Release Tablets nationwide due to failed dissolution specifications. The affected product combines fexofenadine (antihistamine) and pseudoephedrine (decongestant).
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0375-2022·2022-01-19
Clobetasol Propionate Ointment Recalled for Microbial Contamination
Taro Pharmaceuticals is recalling Clobetasol Propionate Ointment USP 0.05% due to the presence of R. Pickettii bacteria in a non-sterile product. The affected lot may have been distributed nationwide through retailers.
Product
CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0369-2022·2022-01-19
Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure
Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0370-2022·2022-01-19
Methylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension 400 mg/10mL due to lack of assurance of sterility. The recall affects one lot distributed to facilities in Tennessee, Mississippi, and Ohio.
Product
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0371-2022·2022-01-19
Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance
Teva Pharmaceuticals is recalling Norepinephrine Bitartrate Injection USP due to lack of assurance of sterility. The affected lot is distributed in Tennessee, Mississippi, and Ohio.
Product
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0372-2022·2022-01-19
Nitroglycerin Lingual Spray Recalled for Defective Delivery System
Padagis US LLC is recalling Nitroglycerin Lingual Spray due to a defective delivery system that may prevent proper medication administration. The recall affects 11,868 bottles distributed nationwide.
Product
NITROGLYCERIN LINGUAL — NITROGLYCERIN LINGUAL (NITROGLYCERIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0362-2022·2022-01-19
Metoprolol Tartrate Tablets Recalled for Foreign Metal in Tablets
Rubicon Research Private Limited is recalling Metoprolol Tartrate 25 mg tablets (batch #210211H1, expiration February 2024) due to a complaint of metal embedded in a tablet.
Product
METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0460-2022·2022-01-19
Sufentanil Citrate Injection Recalled for Subpotency
Akorn, Inc. is recalling Sufentanil Citrate Injection 100 mcg/2 mL due to subpotency—the drug was found to be out of specification for assay at the 30-month stability timepoint. Affected lot 031489A, with expiration 03/31/2022, was distributed nationwide.
Product
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0366-2022·2022-01-19
Metformin 750 mg Extended Release Recalled for NDMA Contamination
RemedyRepack Inc. is recalling Metformin 750 mg Extended Release (NDC # 70518-2920-00) due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding the acceptable daily intake limit. The product was distributed to one direct account in Pennsylvania.
Product
Metformin 750 mg Extended Release NDC # 70518-2920-00
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0365-2022·2022-01-19
Carbamazepine tablets recalled for failed dissolution specifications
Torrent Pharma Inc. is recalling Carbamazepine 200 mg tablets nationwide because they failed to meet dissolution specifications, which means the tablets may not release the medication properly in the body.
Product
CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0368-2022·2022-01-19
Oxycodone Hydrochloride Oral Solution recalled for missing label
Akorn, Inc. is recalling Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL distributed nationwide due to missing label.
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0364-2022·2022-01-19
The Natural Dentist Mouthwash Label Mix-Up Recall
The Natural Dentist Healthy Balance Peppermint Sage mouthwash (16.9 FL OZ, Lot 2091A) has been recalled due to a back label mix-up. The label incorrectly identifies the active ingredient as Menthol with the wrong UPC code instead of the correct Peppermint Oil and Sage Oil.
Product
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0367-2022·2022-01-19
Morphine Sulfate Oral Solution 20 mg/mL recalled for missing label
Akorn, Inc. is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) in 30 mL bottles nationwide due to missing labeling on approximately 10,836 bottles.
Product
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0356-2022·2022-01-12
CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity Specifications
Perrigo Company is recalling CVS Allergy Relief Fexofenadine Hydrochloride 180 mg tablets due to an out-of-specification impurity result found during stability testing. The recall affects one lot distributed nationwide.
Product
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0334-2022·2022-01-12
CAREONE Allergy Relief 180 mg Tablets Recalled for Failed Impurities Specifications
Perrigo Company PLC is recalling CAREONE Allergy Relief (Fexofenadine HCL) 180 mg tablets nationwide because stability testing found impurity A out of specification.
Product
CAREONE ALLERGY RELIEF — CAREONE ALLERGY RELIEF (FEXOFENADINE HCL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0348-2022·2022-01-12
Rite Aid Allergy Relief Fexofenadine tablets recalled for impurity
Perrigo Company PLC is recalling Rite Aid Allergy Relief Fexofenadine Hydrochloride 180mg tablets nationwide due to failed impurity specifications. An out-of-specification result for impurity A was found during stability testing.
Product
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0358-2022·2022-01-12
Oxycodone Hydrochloride Tablets Recalled for Out-of-Specification Impurity
Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets (5 mg) due to out-of-specification impurity test results detected during long-term stability testing. Affected units were distributed in New York and Ohio.
Product
OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0349-2022·2022-01-12
TopCare Allergy Relief Fexofenadine tablets recalled for impurity specification failure
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.
Product
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0360-2022·2022-01-12
Cefixime 400 mg Capsules Recalled for Failed Impurities and Degradation Specifications
RemedyRepack Inc. is recalling Cefixime 400 mg capsules distributed in Michigan and Pennsylvania due to failed impurities and degradation specifications. The affected products may not meet established quality and safety standards.
Product
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0357-2022·2022-01-12
GoodSense Aller.Ease Fexofenadine Recalled for Impurity Specification
Perrigo Company PLC is recalling GoodSense Aller.Ease Fexofenadine hydrochloride 180 mg tablets nationwide due to an out-of-specification impurity detected during stability testing.
Product
GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0342-2022·2022-01-12
MAJOR Fexofenadine Hydrochloride 60mg tablets recalled for failed impurity specifications
Perrigo Company PLC is recalling MAJOR brand Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets due to failed impurities and degradation specifications detected during stability testing.
Product
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0361-2022·2022-01-12
Pregabalin Capsules Recalled for Out-of-Specification Manufacturing Defects
Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.
Product
PREGABALIN — PREGABALIN (PREGABALIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0329-2022·2022-01-12
GoodSense Aller.Ease fexofenadine tablets recalled for impurity specification failure
Perrigo Company PLC is recalling GoodSense Aller.Ease fexofenadine hydrochloride 60 mg tablets nationwide due to failed impurity and degradation specifications identified during stability testing.
Product
GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0340-2022·2022-01-12
H.E.B Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications
H.E.B Allergy Relief fexofenadine hydrochloride tablets (180mg) are being recalled nationwide due to out-of-specification results for impurity A found during stability testing. The affected product is available in 15, 30, and 45 count bottles.
Product
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Ma
Category
Drug
Distribution
Distributed nationwide

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