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

3876–3900 of 11819

SevereFDA (Drugs)·D-0949-2020·2020-03-11
Axia Pharmaceutical Recalls Cyanocobalamin/Folinic Acid Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Cyanocobalamin/Folinic Acid Injection because the product lacks assurance of sterility.
Product
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/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 71283-0333-3
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-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-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-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-0840-2020·2020-02-19
Kushim Tablets Recalled for Unapproved Active Ingredients
B and A Trading Corporation is recalling 40 packages of Kushim Tablets marketed without FDA approval. Analysis found the product contains unapproved active ingredients.
Product
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Category
Drug
Distribution
2 states
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-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
SevereFDA (Drugs)·D-0835-2020·2020-02-19
Pfizer Recalls Fentanyl Citrate Injection Vials Due to Metal Crimp Defects
Pfizer is recalling 38,676 trays of Fentanyl Citrate Injection vials because loose metal overseal crimps may compromise sterility.
Product
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0834-2020·2020-02-19
Zydus Recalls Ethacrynate Sodium Injection Vials Due to cGMP Deviations
Zydus Pharmaceuticals is recalling 2,207 vials of Ethacrynate Sodium for Injection due to current Good Manufacturing Practice (cGMP) deviations.
Product
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0826-2020·2020-02-12
PD-Rx Recalls Ranitidine Hydrochloride Tablets Due to NDMA Contamination
PD-Rx Pharmaceuticals is recalling specific lots of ranitidine hydrochloride 150 mg tablets because a supplier reported potential NDMA levels above established limits.
Product
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-
Category
Drug
Distribution
12 states
SevereFDA (Drugs)·D-0825-2020·2020-02-12
Spectrum Chemical Recalls Ranitidine Hydrochloride Powder Due to NDMA Impurity
Spectrum Laboratory Products is recalling Ranitidine Hydrochloride powder due to the presence of NDMA impurity. The product was distributed to pharmacies in 11 US states and internationally.
Product
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
Category
Drug
Distribution
11 states
HighFDA (Drugs)·D-0828-2020·2020-02-12
Ascend Recalls Olmesartan Medoxomil Tablets Due to cGMP Deviations
Ascend Laboratories is recalling 192 bottles of Olmesartan Medoxomil 20 mg tablets because they were released in error with an alternate API source before approval.
Product
OLMESARTAN MEDOXOMIL — OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0822-2020·2020-02-05
Walgreens Acne Cleansing Bar Recalled for Metal Contaminant
Shandex Personal Care Manufacturing Inc. is recalling Walgreens Acne Cleansing Bar due to the presence of a visible metal contaminant.
Product
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0814-2020·2020-02-05
Sildenafil 200 mg Troche Recall for Labeling and Expiry Issues
Sildenafil 200 mg Troche is recalled for incorrect labeling and being compounded with expired components. Consumers in Texas should check their bottles and contact the manufacturer for instructions.
Product
Sildenafil 200 mg Troche (Clinic)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0798-2020·2020-01-29
RemedyRepack Recalls Ranitidine Tablets Due to Potential NDMA Contamination
RemedyRepack Inc. is recalling specific lots of Ranitidine 150 mg tablets because the supplier reported potential Nitrosodimethylamine (NDMA) levels above established limits.
Product
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0795-2020·2020-01-29
Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity
Denton Pharma is recalling 467 bottles of Ranitidine Tablets 300 mg because of the presence of NDMA impurity. The affected products were distributed nationwide.
Product
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0796-2020·2020-01-29
Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity
Preferred Pharmaceuticals is recalling 150 mg Ranitidine tablets because of detected NDMA impurity. The affected products were distributed to physicians in seven states.
Product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
Category
Drug
Distribution
7 states

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3876–3900 of 11819