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

3826–3850 of 11852

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-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-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-0965-2020·2020-03-11
Axia Pharmaceutical Recalls Methionine Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Methionine/Inositol/Choline Injection due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
Product
Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3
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-0948-2020·2020-03-11
Axia Pharmaceutical Recalls Cyanocobalamin Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Cyanocobalamin Injection because the product lacks assurance of sterility.
Product
Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/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 71283-0330-3
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-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-0978-2020·2020-03-11
Axia Pharmaceutical Recalls Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns
Fusion IV Pharmaceuticals is recalling specific lots of Nicotinamide Adenine Dinucleotide Injection due to a lack of assurance of sterility.
Product
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1
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-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-0994-2020·2020-03-11
Axia Pharmaceutical Recalls Zinc Chloride Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Zinc Chloride Injection because the product lacks assurance of sterility.
Product
Zinc Chloride Injection, ZINC CHLORIDE 10MG/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 71283-0224-3
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
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
SevereFDA (Drugs)·D-0850-2020·2020-02-26
NCS Healthcare Recalls Glycopyrrolate Tablets Due to Impurity Failure
NCS Healthcare of Kentucky Inc is recalling 6,929 blister cards of Glycopyrrolate Tablets, USP, 1 mg, due to high out-of-specification results for an unknown impurity.
Product
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0867-2020·2020-02-19
RemedyRepack Recalls Ketorolac Tromethamine Injections Due to Particulate Matter
RemedyRepack Inc. is recalling 75 vials of Ketorolac Tromethamine 30 mg/1mL injections distributed in Oklahoma and Louisiana due to the presence of small black particles.
Product
Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0852-2020·2020-02-19
AuroMedics Recalls Amoxicillin and Clavulanate Potassium Tablets Due to Foreign Substance
AuroMedics Pharma LLC is recalling 30,432 bottles of Amoxicillin and Clavulanate Potassium tablets because a customer complaint identified a nylon cable tie as a foreign substance.
Product
AMOXICILLIN AND CLAVULANATE POTASSIUM — AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0847-2020·2020-02-19
Efficient Laboratories Recalls Rompe Pecho MAX Due to Microbial Contamination
Efficient Laboratories, Inc. is recalling 4,080 bottles of Rompe Pecho MAX Multi Symptoms due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.
Product
New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0845-2020·2020-02-19
Efficient Laboratories Recalls Rompe Pecho CF Cold & Flu Due to Microbial Contamination
Efficient Laboratories is recalling 5,249 bottles of Rompe Pecho CF Cold & Flu with Honey due to microbial contamination. The product was distributed nationwide in the USA.
Product
Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0833-2020·2020-02-19
Taro Recalls Lamotrigine Tablets Due to Enalapril Maleate Contamination
Taro Pharmaceuticals is recalling Lamotrigine Tablets 100 mg because they were cross-contaminated with enalapril maleate. The affected lot was distributed nationwide in the U.S. and Puerto Rico.
Product
LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0839-2020·2020-02-19
Akorn Recalls Subpotent Hydrocortisone and Acetic Acid Otic Solution
Akorn Inc is recalling 16,078 bottles of Hydrocortisone and Acetic Acid Otic Solution due to low assay results for the hydrocortisone component.
Product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0857-2020·2020-02-19
Contract Pharmacal Recalls Leader Extra Strength Acetaminophen Tablets
Contract Pharmacal is recalling Leader Extra Strength Acetaminophen tablets due to a complaint about a foreign prenatal tablet found in the bottle.
Product
Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0846-2020·2020-02-19
Rompe Pecho EX Expectorant Recalled for Microbial Contamination
Efficient Laboratories, Inc. is recalling 5,387 bottles of Rompe Pecho EX Expectorant due to microbial contamination. Consumers should stop using the product and return it to the place of purchase.
Product
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
Category
Drug
Distribution
Distributed nationwide

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3826–3850 of 11852