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

6601–6625 of 11856

HighFDA (Drugs)·D-1125-2017·2017-09-06
Morton Grove Recalls Amoxicillin and Clavulanate Potassium Oral Suspension
Morton Grove Pharmaceuticals is recalling 7,332 bottles of Amoxicillin and Clavulanate Potassium Oral Suspension due to a customer complaint of a blue nitrile glove fragment found in the product.
Product
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1117-2017·2017-08-30
CaverFlo Natural Herbal Coffee Recalled for Undeclared Sildenafil and Tadalafil
The FDA is recalling CaverFlo Natural Herbal Coffee because it contains undeclared sildenafil, tadalafil, and milk. The product was marketed without an approved NDA or ANDA.
Product
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-1111-2017·2017-08-30
Phenobarbital Tablets Recalled Due to Incorrect Strength Labeling
C. O. Truxton is recalling Phenobarbital 15 mg tablets that were actually 30 mg due to a labeling error.
Product
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1123-2017·2017-08-30
Rugby Senexon Liquid Recalled for Microbial Contamination
The Harvard Drug Group is recalling Rugby Senexon Liquid due to microbial contamination, including yeast and potential B. cepacia.
Product
Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1119-2017·2017-08-30
Rugby Diocto Liquid Recalled for Microbial Contamination
The Harvard Drug Group is recalling Rugby Diocto Liquid due to microbial contamination, including yeast and potential B. cepacia.
Product
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1120-2017·2017-08-30
Rugby Diocto Syrup Recalled for Microbial Contamination
The Harvard Drug Group is recalling Rugby Diocto Syrup due to microbial contamination, including yeast and potential B. cepacia.
Product
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1121-2017·2017-08-30
Major Senna Syrup Recalled for Microbial Contamination
The Harvard Drug Group is recalling Major Senna Syrup due to microbial contamination, including yeast and potential B. cepacia.
Product
Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1122-2017·2017-08-30
Rugby Aller-chlor Syrup Recalled for Microbial Contamination
The Harvard Drug Group is recalling 4,715 bottles of Rugby Aller-chlor syrup due to microbial contamination, including yeast and potential B. cepacia.
Product
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1112-2017·2017-08-30
C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error
C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 30 mg, because they may be mislabeled. The FDA classifies this as a Class I recall.
Product
Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1092-2017·2017-08-23
GEC LX Laxoplex Recalled for Undeclared Anabolic Steroids
Genetic Edge Compounds LLC is recalling GEC LX Laxoplex dietary supplements because FDA analysis found the product tainted with undeclared anabolic steroids and steroid-like substances.
Product
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1087-2017·2017-08-23
Biotech Underground Tri-Ton Hardcore Formula Recalled for Unapproved Ingredients
Dynamic Technical Formulations is recalling Biotech Underground Tri-Ton Hardcore Formula capsules because FDA testing found unapproved drug ingredients.
Product
Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1091-2017·2017-08-23
ICU Medical Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
ICU Medical Inc. is recalling 436,716 units of 0.9% Sodium Chloride Injection due to the presence of stainless steel particulate matter.
Product
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1096-2017·2017-08-23
FDA Recalls Unapproved Caffeine Powder Marketed Without NDA Approval
Global Marketing Enterprises is recalling 52.5 kg of unapproved caffeine powder marketed with stimulant claims and lacking adequate directions for use.
Product
Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-1093-2017·2017-08-23
Lupin Recalls Mibelas 24 Fe Contraceptive Tablets Due to Sequence Error
Lupin Limited is recalling Mibelas 24 Fe tablets because the first four pills in the packet are brown instead of the last four, and the expiry/lot was not printed on the package.
Product
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceutic
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1085-2017·2017-08-23
Hardcore Formulations Recalls D-ZINE Rapid Size and Strength Capsules
Hardcore Formulations is recalling D-ZINE Rapid Size and Strength capsules because they contain unapproved active ingredients.
Product
D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1084-2017·2017-08-23
FDA Recalls Ultra-Sten Capsules Marketed Without Approval
Hardcore Formulations is recalling Ultra-Sten capsules because they contain unapproved ingredients and were marketed without an approved NDA or ANDA.
Product
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1086-2017·2017-08-23
Amgen Recalls Procrit Erythropoietin Vials Due to Visible Glass Flakes
Amgen is recalling 175,632 vials of Procrit (Erythropoietin) because visible glass flakes were identified in some drug product vials.
Product
PROCRIT — PROCRIT (ERYTHROPOIETIN)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1064-2017·2017-08-16
Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling Ephedrine Sulfate syringes due to a lack of sterility assurance. The recall covers 49,666 syringes distributed nationwide.
Product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1070-2017·2017-08-16
Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 8,928 bags of Norepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL due to a lack of sterility assurance.
Product
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1068-2017·2017-08-16
Cantrell Drug Recalls Succinylcholine Chloride Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride Injection Solution due to a lack of sterility assurance.
Product
Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1071-2017·2017-08-16
Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 1,718 bags of Norepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to a lack of sterility assurance.
Product
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1079-2017·2017-08-16
Cantrell Drug Company Recalls Rocuronium Bromide Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Rocuronium Bromide Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide in the US.
Product
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1073-2017·2017-08-16
Cantrell Drug Recalls Diltiazem HCl Bags Due to Sterility Concerns
Cantrell Drug Company is recalling Diltiazem HCl 125 mg in 5% Dextrose single-dose bags because of a lack of sterility assurance. The recall covers 2,761 bags distributed nationwide.
Product
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1075-2017·2017-08-16
Cantrell Drug Recalls Sodium Bicarbonate Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Sodium Bicarbonate 8.4% Injection Solution because of a lack of sterility assurance.
Product
Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1062-2017·2017-08-16
Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling Ephedrine Sulfate in 0.9% Sodium Chloride single-dose syringes because of a lack of sterility assurance.
Product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
Category
Drug
Distribution
Distributed nationwide

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6601–6625 of 11856