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

6376–6400 of 17772

SevereFDA (Drugs)·D-0979-2020·2020-03-11
Axia Pharmaceutical Recalls Iohexol Injection Due to Sterility Concerns
Fusion IV Pharmaceuticals is recalling Iohexol Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in specific international locations.
Product
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0970-2020·2020-03-11
Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.
Product
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0639-2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0946-2020·2020-03-11
Axia Pharmaceutical Recalls Calcium Chloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Calcium Chloride Injection due to a lack of assurance of sterility. The affected product was distributed nationwide and in several international locations.
Product
Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0963-2020·2020-03-11
Axia Pharmaceutical Recalls Lysine Hydrochloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Lysine Hydrochloride Injection because the company cannot ensure the product is sterile.
Product
Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0988-2020·2020-03-11
Axia Pharmaceutical Recalls Triamcinolone Acetonide Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Triamcinolone Acetonide Injectable Suspension because the company cannot ensure the product is sterile.
Product
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0938-2020·2020-03-11
Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
Product
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0975-2020·2020-03-11
Axia Pharmaceutical Recalls MIC-PLUS Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling MIC-PLUS Injection, a vitamin complex, due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.
Product
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0231-3
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0961-2020·2020-03-11
Axia Pharmaceutical Recalls Levocarnitine Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Levocarnitine Injection because the company cannot guarantee the product's sterility.
Product
Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0951-2020·2020-03-11
Axia Pharmaceutical Recalls Dexamethasone Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling Dexamethasone (LA) Injectable Suspension because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
Product
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0993-2020·2020-03-11
Axia Pharmaceutical Recalls Vitamin D3 Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Vitamin D3 Injection because the product may lack assurance of sterility.
Product
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0985-2020·2020-03-11
Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Testosterone Cypionate/Progesterone Injection due to a lack of assurance of sterility.
Product
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0969-2020·2020-03-11
Axia Pharmaceutical Recalls Methylprednisolone Acetate/Bupivacaine Injectable Suspension
Axia Pharmaceutical is recalling Methylprednisolone Acetate/Bupivacaine Injectable Suspension due to a lack of assurance of sterility.
Product
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0959-2020·2020-03-11
Axia Pharmaceutical Recalls Arginine Hydrochloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Arginine Hydrochloride Injection because the product lacks assurance of sterility.
Product
Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0995-2020·2020-03-11
Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns
Pfizer is recalling 24,714 vials of Elelyso (taliglucerase alfa) for injection due to reports of loose metal ferrule crimps that compromise sterility.
Product
ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0984-2020·2020-03-11
Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Testosterone Cypionate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
Product
Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0967-2020·2020-03-11
Axia Pharmaceutical Recalls Methylcobalamin Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Methylcobalamin Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
Product
Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0331-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0986-2020·2020-03-11
Recall of Triamcinolone Acetonide/Bupivacaine Injectable Suspension Due to Sterility Concerns
FDA recalls Triamcinolone Acetonide/Bupivacaine Injectable Suspension due to lack of sterility assurance. The drug was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.
Product
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0862-2020·2020-03-11
Teva Recalls Mesalamine Tablets Due to Dissolution Test Failures
Teva Pharmaceuticals USA is recalling 3,695 bottles of Mesalamine Delayed-Release Tablets because stability testing showed low dissolution results.
Product
MESALAMINE — MESALAMINE (MESALAMINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0964-2020·2020-03-11
Axia Pharmaceutical Recalls Magnesium Chloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Magnesium Chloride Injection because the company cannot assure the product's sterility.
Product
Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0868-2020·2020-03-11
AAA Pharmaceutical Recalls Fexofenadine Tablets for Labeling Errors
AAA Pharmaceutical, Inc. is recalling specific lots of Discount Drug Mart Fexofenadine Hydrochloride Tablets due to incorrect or missing lot and expiration dates.
Product
Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distribute
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0863-2020·2020-03-04
Taro Recalls Phenytoin Oral Suspension Due to Resuspension Issues
Taro Pharmaceuticals is recalling two lots of Phenytoin Oral Suspension because the medication may coagulate and fail to resuspend as directed.
Product
PHENYTOIN — PHENYTOIN (PHENYTOIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1063-2020·2020-03-04
Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures
Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.
Product
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hun
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0860-2020·2020-03-04
Akorn Recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment Due to Particulate Matter
Akorn, Inc. is recalling specific tubes of Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper.
Product
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0861-2020·2020-03-04
CVS Health Sodium Chloride Ophthalmic Ointment Recalled for Particulate Matter
Akorn, Inc. is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper inside the tubes.
Product
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0856-2020·2020-03-04
Golden State Medical Supply Recalls Tramadol Tablets Due to Labeling Error
Golden State Medical Supply is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.
Product
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
Category
Drug
Distribution
Distributed nationwide

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6376–6400 of 17772