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 the agency’s own highest classification or reported deaths or serious injuries, 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

15076–15100 of 18042

ModerateFDA (Drugs)·D-1541-2014·2014-08-27
Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failures
Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing. The recall covers 11,661 bottles distributed nationwide.
Product
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1544-2014·2014-08-27
Triveen PRx RNF Capsules Recalled for Incorrect Vitamin B12 Labeling
Trigen Laboratories is recalling Triveen PRx RNF Capsules because the label lists Vitamin B12, which is not in the formulation.
Product
Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1539-2014·2014-08-27
Mylan Recalls Tolterodine Tartrate Tablets Due to Impurity Failures
Mylan Pharmaceuticals is recalling 9,225 bottles of Tolterodine Tartrate Tablets, 1 mg, because the product failed impurity specifications for lactol and total impurities.
Product
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1535-2014·2014-08-20
Super ARTHGOLD Recalled for Undeclared Prescription Drugs
Super ARTHGOLD dietary supplement is being recalled because it contains undeclared prescription drugs and was marketed without FDA approval.
Product
Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1534-2014·2014-08-20
Lite Fit USA Recalled for Undeclared Sibutramine
Bacai, Inc. is voluntarily recalling Lite Fit USA supplements containing undeclared sibutramine, making them unapproved new drugs.
Product
Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1538-2014·2014-08-20
Teva Recalls Carbidopa and Levodopa Tablets Due to Potential Superpotency
Teva Pharmaceuticals USA is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg, due to the potential for superpotent tablets.
Product
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1536-2014·2014-08-20
Bracco Recalls E-Z-HD Barium Sulfate Due to Low Potency
Bracco Diagnostic Inc is recalling E-Z-HD (barium sulfate) bottles because routine stability testing revealed low pH and assay results.
Product
E-Z-HD — E-Z-HD (BARIUM SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1537-2014·2014-08-20
Pfizer Recalls Depo-Medrol Vials Due to pH Specification Failure
Pfizer is recalling 93,800 vials of Depo-Medrol (methylprednisolone acetate) because a stability test showed a pH level below the registered specification.
Product
DEPO-MEDROL — DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1524-2014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin 5000 Injection USP because the manufacturer is not registered with the FDA.
Product
Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1512-2014·2014-08-13
Alexion Recalls Soliris Vials Due to Visible Particulate Matter
Alexion Pharmaceuticals is recalling 96,506 vials of Soliris (eculizumab) because the product failed appearance tests for visible particles under labeled storage conditions.
Product
SOLIRIS — SOLIRIS (ECULIZUMAB)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1514-2014·2014-08-13
Janssen Recalls Risperdal CONSTA Due to Sterility Failure
Janssen Pharmaceuticals is recalling one lot of Risperdal CONSTA (risperidone) 25 mg dose packs due to a sterility failure detected in a stability sample.
Product
RISPERDAL CONSTA — RISPERDAL CONSTA (RISPERIDONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1523-2014·2014-08-13
FDA Recalls Unapproved Vitamin B6 Injection Vials Nationwide
Medical Supply Liquidators LLC is recalling Vitamin B6 Pyridoxine HCL for Injection because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1531-2014·2014-08-13
FDA Recalls G.A.C. 375 Injection Due to Unregistered Manufacturer
The FDA is recalling G.A.C. 375 Injection USP because the manufacturing firm is not registered with the FDA as a drug manufacturer.
Product
G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1529-2014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injection Vials
Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1532-2014·2014-08-13
L-Carnitine Injection Recalled for Lack of FDA Approval and Registration
Medical Supply Liquidators LLC is recalling L-Carnitine Injection USP 100 mg/ml because it was marketed without an approved NDA/ANDA and the manufacturer is not registered with the FDA.
Product
L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1528-2014·2014-08-13
B Complex Injection Recalled for Lack of FDA Approval
Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.
Product
B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1521-2014·2014-08-13
BCAA 4% Injection Recalled for Lack of FDA Approval
Medical Supply Liquidators LLC is recalling BCAA 4% Branched Chain Amino Acid Injection USP because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.
Product
BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1526-2014·2014-08-13
Unapproved Injectable B Complex Recall Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Super MIC B Complex injections because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1530-2014·2014-08-13
FDA Recalls Unapproved Lipo 8 Injection Vials Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Lipo 8 Injection USP 200 mg/ml vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1515-2014·2014-08-13
Sandoz Alprazolam Tablets Recalled for Stainless Steel Metal Particulates
Mckesson Packaging Services is recalling Sandoz Alprazolam Tablets 0.25 mg due to the presence of stainless steel metal particulates.
Product
Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1511-2014·2014-08-13
Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations
Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.
Product
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1518-2014·2014-08-13
Alcohol-Free Hand Sanitizer Recalled for Microbial Contamination
HLI dba Humphreyline Inc is recalling 975 bottles of alcohol-free hand sanitizer due to microbial contamination. The product was distributed in Kentucky, Maryland, and Virginia.
Product
Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson…
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-1533-2014·2014-08-13
FDA Recalls Unapproved Glutathione Injection Vials Nationwide and Abroad
Medical Supply Liquidators LLC is recalling Glutathione Injection USP vials because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.
Product
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1519-2014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1520-1014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin Injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA or ANDA.
Product
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide

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15076–15100 of 18042