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

4501–4525 of 11852

SevereFDA (Drugs)·D-0107-2020·2019-10-09
KRS Global Biotechnology Recalls Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.
Product
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0049-2020·2019-10-09
FDA Recalls Fentanyl IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.
Product
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0111-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin D Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.
Product
Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0121-2020·2019-10-09
Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 50mg because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0048-2020·2019-10-09
KRS Global Biotechnology Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling ePHEDrine Sulfate syringes nationwide because the company cannot guarantee the product is sterile.
Product
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0005-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.01% due to a lack of assurance of sterility.
Product
C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0062-2020·2019-10-09
KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.
Product
Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0063-2020·2019-10-09
KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 30 mg/30 mL for IM use due to a lack of assurance of sterility.
Product
Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0015-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Interferon Alfa2B Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Interferon Alfa2B ophthalmic solution because the product's sterility cannot be guaranteed.
Product
C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0056-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,620 vials of Human Chorionic Gonadotropin 11,000 Units due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0110-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,747 vials of Vitamin 10 B Lyophilized for IM use nationwide due to a lack of assurance of sterility.
Product
Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0003-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific lots of C-Acetylcysteine Ophthalmic 10% Solution because the sterility of the product cannot be guaranteed.
Product
C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0053-2020·2019-10-09
KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0036-2020·2019-10-02
Natpara Injection Cartridges Recalled for Potential Needle Clogging
Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing underdosing.
Product
Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
Category
Drug
Distribution
0 states
CriticalFDA (Drugs)·D-0125-2020·2019-10-02
FDA Recalls Quinacrine Dihydrochloride Bulk API Due to Labeling Error
Darmerica, LLC is recalling 1.8 kilograms of bulk Quinacrine Dihydrochloride API because testing revealed the product was actually Artemisinin.
Product
Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0038-2020·2019-10-02
Natpara Injection Recall Issued for Potential Needle Clogging and Underdosing
Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.
Product
Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0037-2020·2019-10-02
Natpara Injection Cartridges Recalled for Potential Needle Clogging
Shire is recalling Natpara (parathyroid hormone) injection cartridges because rubber stopper particles may clog the needle, leading to underdosing.
Product
Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0035-2020·2019-10-02
Natpara Injection Recall Due to Potential Needle Clogging and Underdosing
Shire is recalling Natpara (parathyroid hormone) injections because rubber stopper particles may clog the needle, potentially causing underdosing.
Product
Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1881-2019·2019-10-02
Johnson Matthey Recalls Cisplatin Active Pharmaceutical Ingredient Due to Glass Contamination
Johnson Matthey Inc. is recalling 26,625 grams of Cisplatin Active Pharmaceutical Ingredient due to potential glass contamination.
Product
Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1872-2019·2019-09-25
Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures
Aurolife Pharma is recalling 240 bottles of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.
Product
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1859-2019·2019-09-25
Superior Pain & Itch Relief Lidocaine Gel Recalled for Contamination
Ridge Properties, LLC is recalling Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, because the product was found to be contaminated and above specification for lidocaine assay.
Product
Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1873-2019·2019-09-25
Aurolife Pharma Recalls Wal-Fex Tablets Due to Impurity Failures
Aurolife Pharma is recalling 4,920 cartons of Wal-Fex (Fexofenadine Hydrochloride) 180 mg tablets nationwide because they failed impurity and degradation specifications.
Product
Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1860-2019·2019-09-25
Soothing Sore Relief Lidocaine Cream Recalled for High Potency
Ridge Properties, LLC is recalling Soothing Sore Relief (lidocaine) Cream, 4%, because the product was found to be contaminated and above specification for lidocaine assay.
Product
Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1864-2019·2019-09-25
Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures
Aurolife Pharma is recalling 8,240 bottles of Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity and degradation specifications.
Product
Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1868-2019·2019-09-25
Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures
Aurolife Pharma is recalling specific lots of Fexofenadine Hydrochloride 180 mg tablets because they failed impurity and degradation specifications.
Product
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Category
Drug
Distribution
Distributed nationwide

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4501–4525 of 11852