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

8301–8325 of 8593

SevereFDA (Drugs)·D-130-2013·2013-01-30
West-ward Recalls Lisinopril Tablets Due to Foreign Substance Presence
West-ward Pharmaceutical Corp. is recalling specific lots of Lisinopril Tablets, USP 40 mg, because uncharacteristic black spots were found in the tablets.
Product
Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-131-2013·2013-01-30
West-ward Recalls Propylthiouracil Tablets Due to Foreign Substance Presence
West-ward Pharmaceutical Corp. is recalling specific lots of Propylthiouracil Tablets, USP, 50 mg because uncharacteristic spots identified as steel corrosion, degraded tablet material, and hydrocarbon oil were found.
Product
Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-135-2013·2013-01-30
Genentech Recalls Trastuzumab Kits Due to Potential Glass Particulates
Genentech is recalling 2,140 Trastuzumab Kits for investigational use because the included Bacteriostatic Water for Injection diluent vials may contain glass particulates.
Product
Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reco
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-125-2013·2013-01-23
Perrigo Recalls Prednisone Tablets Due to Foreign Substance Contamination
L. Perrigo Co. is recalling specific lots of 10mg Prednisone tablets contaminated with trace food-grade lubricant and stainless steel inclusions.
Product
Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-111-2013·2013-01-09
FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 3,822 vials of Methylprednisolone Acetate 80 mg/mL Injection nationwide due to non-sterility concerns.
Product
Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-108-2013·2013-01-09
FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 23,897 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.
Product
Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-109-2013·2013-01-09
FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 9,062 vials of Methylprednisolone Acetate Injection because they may not be sterile. The recall is nationwide.
Product
Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-110-2013·2013-01-09
FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 5,130 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.
Product
Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-115-2013·2013-01-09
New England Compounding Center Recalls Clonidine Vials Due to Sterility Concerns
New England Compounding Center is recalling Clonidine 100 mcg/mL vials nationwide due to a lack of assurance of sterility.
Product
Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-119-2013·2013-01-09
New England Compounding Center Recalls Isovue Vials Due to Sterility Concerns
New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.
Product
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-112-2013·2013-01-09
New England Compounding Center Recalls Betamethasone Repository Injections
New England Compounding Center is recalling Betamethasone Repository injections due to a lack of assurance of sterility. The recall covers all lot codes distributed nationwide.
Product
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-116-2013·2013-01-09
New England Compounding Center Recalls Dexamethasone Sodium Phosphate Vials
New England Compounding Center is recalling Dexamethasone Sodium Phosphate vials due to a lack of assurance of sterility.
Product
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-106-2013·2013-01-09
Hospira Recalls Epinephrine Injection Due to Potential Glass Particulates
Hospira is recalling specific lots of Epinephrine Injection USP because they may contain glass particles.
Product
Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-114-2013·2013-01-09
New England Compounding Center Recalls Bupivacaine Products Due to Sterility Concerns
New England Compounding Center is recalling Bupivacaine 0.25%, 0.5%, and 0.75% PF products because the agency cannot assure the sterility of the medication.
Product
Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-121-2013·2013-01-09
New England Compounding Center Recalls Lidocaine Vials Due to Sterility Concerns
New England Compounding Center is recalling Lidocaine vials because the FDA determined there is a lack of assurance of sterility.
Product
Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-117-2013·2013-01-09
New England Compounding Center Recalls Glycerin 100% Vials for Sterility Concerns
New England Compounding Center is recalling 165 vials of Glycerin 100% PF due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-113-2013·2013-01-09
Betamethasone Sodium Phosphate Injection Recalled for Sterility Concerns
New England Compounding Center is recalling Betamethasone Sodium Phosphate injections due to a lack of assurance of sterility.
Product
Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-120-2013·2013-01-09
New England Compounding Center Recalls Lidocaine Dextrose Due to Sterility Concerns
New England Compounding Center is recalling Lidocaine/Dextrose 5%/7.5% PF nationwide due to a lack of assurance of sterility.
Product
Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-118-2013·2013-01-09
New England Compounding Center Recalls Hyaluronidase Vials Due to Sterility Concerns
New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials nationwide because the FDA determined there is a lack of assurance of sterility.
Product
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-104-2013·2013-01-02
Alara Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Issues
Alara Pharmaceutical is recalling 7,432 bottles of Levothyroxine Sodium Tablets because the product is subpotent and has stability issues.
Product
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-105-2013·2013-01-02
Roche Recalls Cymevene Powder for Infusion Due to Sterility Concerns
F. Hoffmann-LaRoche Ltd. is recalling Cymevene 500 mg Powder for Infusion due to container closure issues that compromise sterility assurance. No product was distributed in the USA.
Product
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-100-2013·2013-01-02
Lloyd Inc. Recalls Subpotent Thyro-Tab 0.050 mg. Tablets
Lloyd Inc. of Iowa is recalling specific lots of Thyro-Tab 0.050 mg. tablets because they are subpotent and have a 9-month stability interval.
Product
Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-101-2013·2013-01-02
Lloyd Inc. of Iowa Recalls Subpotent Levothroid Levothyroxine Sodium Tablets
Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium) tablets because they are subpotent and have a 9-month stability interval.
Product
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-099-2013·2012-12-26
Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter
Hospira is recalling Lidocaine Hydrochloride Injection vials because visible particulate matter embedded in the glass wall may dislodge into the product.
Product
LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-096-2013·2012-12-26
Hospira Recalls Nalbuphine Hydrochloride Injection Due to Sterility Concerns
Hospira is recalling 145,400 vials of Nalbuphine Hydrochloride Injection because loose crimps and missing stoppers prevent assurance of sterility.
Product
NALBUPHINE HYDROCHLORIDE — NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide

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8301–8325 of 8593