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

14851–14875 of 17799

SevereFDA (Drugs)·D-1554-2014·2014-08-27
Healix Recalls Fentanyl Syringes Due to Sterility Concerns
Healix Infusion Therapy is recalling 220 fentanyl prefilled syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.
Product
fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar…
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1540-2014·2014-08-27
Hospira Recalls Dobutamine Injection Vials Due to Glass Particulate Matter
Hospira Inc. is recalling 123,900 vials of Dobutamine Injection due to the presence of glass particulate matter and a discolored solution.
Product
DOBUTAMINE — DOBUTAMINE (DOBUTAMINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1552-2014·2014-08-27
Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
Healix Infusion Therapy is recalling 48 bags of compounded fentanyl in Texas and Georgia because the supplier recalled the source drug due to loose or missing vial crimps.
Product
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive…
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1553-2014·2014-08-27
Healix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns
Healix Infusion Therapy is recalling 12 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility from a supplier recall.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at…
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1545-2014·2014-08-27
Fresenius Kabi Recalls Propranolol Hydrochloride Injection Due to API Deficiencies
Fresenius Kabi USA, LLC is recalling 56,060 vials of Propranolol Hydrochloride Injection because the active ingredient supplier received citations for critical manufacturing deficiencies.
Product
PROPRANOLOL — PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1555-2014·2014-08-27
Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
Healix Infusion Therapy is recalling compounded fentanyl infusion bags distributed in Texas and Georgia because the supplier recalled the source fentanyl due to loose or missing vial crimps.
Product
fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive…
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1547-2014·2014-08-27
Hospira Recalls Propofol Vials Due to Metallic Particulate Matter
Hospira Inc. is recalling 844,300 vials of Propofol Injectable Emulsion because glass defects allowed metallic particulates to enter the solution.
Product
PROPOFOL — PROPOFOL (PROPOFOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1549-2014·2014-08-27
Doctor's Best Red Yeast Rice Recalled for Undeclared Lovastatin
Doctor's Best is recalling Red Yeast Rice 1200 capsules because FDA analysis found undeclared lovastatin, making it an unapproved new drug.
Product
Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1542-2014·2014-08-27
Baxter Recalls ProSol Amino Acid Injection Due to Particulate Matter
Baxter Healthcare is recalling 6,204 bags of ProSol Amino Acid Injection because a retention sample contained particulate matter. The product was distributed nationwide.
Product
PROSOL — PROSOL (VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1548-2014·2014-08-27
US Compounding Recalls Mislabeled Ephedrine Sulfate Injection Syringes
US Compounding Inc is recalling 762 syringes of ephedrine sulfate injection due to a labeling error on the outer protective bags that could cause confusion regarding the drug's strength.
Product
ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
Category
Drug
Distribution
Distributed nationwide
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

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14851–14875 of 17799