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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

FDC Limited

Class I - Dangerous

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Mar 11, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.

Mylan Institutional

Class I - Dangerous

Super-Potent Drug: Out of specification potency results were obtained.

Mar 7, 2025 Prescription Drugs Nationwide View Details →

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

Slate Run Pharmaceuticals

Class I - Dangerous

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Mar 7, 2025 Prescription Drugs Nationwide View Details →

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Subpotent Drug

Feb 17, 2025 Compounded Drugs Nationwide View Details →

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Subpotent Drug

Feb 17, 2025 Compounded Drugs Nationwide View Details →

Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015

Fruit Of The Earth

Class I - Dangerous

Chemical contamination: presence of benzene

Mar 11, 2025 Other Drugs Nationwide View Details →

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

One Source Nutrition, Inc,

Class I - Dangerous

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

Feb 20, 2025 Prescription Drugs Nationwide View Details →

Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).

Amgen

Class I - Dangerous

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Feb 27, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.

Mylan Institutional

Class I - Dangerous

Super-Potent Drug: Out of specification potency results were obtained.

Mar 7, 2025 Prescription Drugs Nationwide View Details →

Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

Slate Run Pharmaceuticals

Class I - Dangerous

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Mar 7, 2025 Prescription Drugs Nationwide View Details →

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

Golden State Medical Supply

Class I - Dangerous

Failed Dissolution Specifications

Mar 5, 2025 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

Rising Pharma Holding

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Mar 5, 2025 Prescription Drugs Nationwide View Details →

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0

Chattem

Class I - Dangerous

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

Mar 4, 2025 Prescription Drugs Nationwide View Details →

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

Aspen Biopharma Labs Pvt.

Class I - Dangerous

CGMP Deviations

Feb 7, 2025 Other Drugs View Details →

Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

Aspen Biopharma Labs Pvt.

Class I - Dangerous

CGMP Deviations

Feb 7, 2025 Other Drugs View Details →

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case

Kowa Pharmaceuticals America

Class I - Dangerous

Presence of foreign tablets/capsules

Feb 24, 2025 Prescription Drugs View Details →

Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1

Denison Pharmaceuticals

Class I - Dangerous

Chemical Contamination: Presence of benzene.

Feb 24, 2025 Other Drugs Nationwide View Details →

Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916

Johnson, S C and Son

Class I - Dangerous

Chemical Contamination

Feb 13, 2025 Other Drugs Nationwide View Details →

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

ICU Medical

Class I - Dangerous

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

Feb 13, 2025 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Feb 28, 2025 Prescription Drugs Nationwide View Details →