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

4501–4525 of 17762

ModerateFDA (Drugs)·D-0373-2022·2022-01-26
Brinzolamide Ophthalmic Suspension recalled for defective container caps
Teva Pharmaceuticals is recalling Brinzolamide Ophthalmic Suspension 1% due to defective container caps. The notch in the dropper cap could break off and block dispensing of the medication.
Product
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0391-2022·2022-01-26
Extra Strength Headache tablets recalled for CGMP manufacturing deviations
Medique Products is recalling Extra Strength Headache tablets nationwide after an FDA inspection found they were not manufactured under Current Good Manufacturing Practices.
Product
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0381-2022·2022-01-26
Fexofenadine/Pseudoephedrine tablets recalled for failed dissolution
Dr. Reddy's Laboratories is recalling Kroger Allergy Relief-D tablets (fexofenadine HCl 60mg/pseudoephedrine HCl 120mg) due to failed dissolution specifications. Approximately 11,064 boxes distributed nationwide are affected.
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0382-2022·2022-01-26
Dr. Reddy's Fexofenadine/Pseudoephedrine Tablets Fail Dissolution Specification
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets because the tablets failed to meet dissolution specifications, which may affect the drug's effectiveness.
Product
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0387-2022·2022-01-26
Lexette Topical Foam Recall Due to Dispensing Defects
Mayne Pharma is recalling Lexette (halobetasol propionate) Topical Foam 0.05% due to manufacturing defects that cause the product to either not dispense or dispense liquid instead of foam. The recall affects 17,113 canisters distributed nationwide.
Product
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0379-2022·2022-01-26
Rugby Antihistamine and Decongestant Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Rugby brand antihistamine and nasal decongestant tablets nationwide due to failed dissolution specifications. The affected product is NDC 0536-1242-07, Lot #AC2106452F with expiration date 3/31/2023.
Product
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, 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
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-0388-2022·2022-01-26
Drug Recall: Mucus Relief D Subpotent Tablets
Dr. Reddy's Laboratories is recalling Mucus Relief D (Guaifenesin Pseudoephedrine HCl ER Tablets) nationwide due to subpotency. The affected product was distributed to Walgreen Co. stores across the USA.
Product
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3
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-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-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-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
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
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-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
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
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-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-0350-2022·2022-01-12
TopCare Allergy Relief Fexofenadine tablets recalled for impurity specifications
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.
Product
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90
Category
Drug
Distribution
Distributed nationwide
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-0355-2022·2022-01-12
Kirkland Aller-Fex tablets recalled for impurity specification failure
Perrigo Company is recalling Kirkland Aller-Fex fexofenadine hydrochloride 180 mg tablets nationwide because stability testing found out-of-specification impurity levels in affected lots.
Product
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, U
Category
Drug
Distribution
Distributed nationwide

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4501–4525 of 17762