Drug Recalls

2,059 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,701–1,750 of 2,059

Drug Recall · May 7, 2024
PACIRA PHARMACEUTICALS INC
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Class II
Drug Recall · May 7, 2024
MACLEODS PHARMA USA, INC
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceut
Presence of foreign substance: plastic-like substance.
Class II
Drug Recall · May 6, 2024
Rubicon Research Private Limited
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India
Presence of Foreign Substance: metal in tablet
Class II
Drug Recall · May 2, 2024
RemedyRepack Inc.
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Class II
Drug Recall · May 1, 2024
Pharma Nobis LLC
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II
Drug Recall · May 1, 2024
Dr. Reddy's Laboratories, Inc.
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Failed Impurities/Degradation Specifications
Class III
Drug Recall · May 1, 2024
Pharma Nobis LLC
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II
Drug Recall · April 30, 2024
Hikma Injectables USA Inc
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by
Labeling: Wrong Barcode
Class III
Drug Recall · April 30, 2024
Viatris Inc
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Failed Impurities/Degradation Specifications
Class II
Drug Recall · April 30, 2024
Viatris Inc
Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
Failed Impurities/Degradation Specifications
Class II
Drug Recall · April 29, 2024
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Bar
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · April 29, 2024
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Ber
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · April 29, 2024
Hikma Injectables USA Inc
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Class I
Drug Recall · April 29, 2024
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc.,
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · April 26, 2024
Rubicon Research Private Limited
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Resea
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class II
Drug Recall · April 25, 2024
Viatris Inc
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class III
Drug Recall · April 25, 2024
FDC Limited
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distr
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Class II
Drug Recall · April 25, 2024
Sagent Pharmaceuticals
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC:
Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II
Drug Recall · April 24, 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II
Drug Recall · April 24, 2024
Aurobindo Pharma USA Inc.
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeto
Discoloration: Dotted and yellow spots on tablets
Class II
Drug Recall · April 24, 2024
SOMERSET THERAPEUTICS LLC
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics,
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II
Drug Recall · April 24, 2024
Acella Pharmaceuticals, LLC
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Subpotent drug
Class III
Drug Recall · April 24, 2024
Aurobindo Pharma USA Inc.
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeto
Discoloration: Dotted and yellow spots on tablets
Class II
Drug Recall · April 24, 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II
Drug Recall · April 24, 2024
Coast Quality Pharmacy, LLC dba Anazao Health
Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II
Drug Recall · April 23, 2024
EPI Health, LLC
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403,
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II
Drug Recall · April 23, 2024
EPI Health, LLC
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403,
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II
Drug Recall · April 23, 2024
EPI Health, LLC
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II
Drug Recall · April 23, 2024
Regeneron Pharmaceuticals Inc
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown,
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II
Drug Recall · April 22, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Failed Release Testing: Out of specification for particulate matter test.
Class III
Drug Recall · April 22, 2024
Stop Clopez Corp
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Marketed Without An Approved NDA/ANDA
Class I
Drug Recall · April 20, 2024
Revive Rx LLC dba Revive Rx Pharmacy
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class I
Drug Recall · April 19, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Ro
Out of specification for assay
Class II
Drug Recall · April 19, 2024
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 19, 2024
Nomax Inc
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 19, 2024
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 19, 2024
Nomax Inc
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Ti
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Bo
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, ww
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquer
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufac
Out of Specification for active ingredient
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brand
Out of Specification for active ingredient
Class II
Drug Recall · April 17, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of
Failed Dissolution Specifications
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Bo
Out of Specification for active ingredient
Class II
Drug Recall · April 12, 2024
Dercher Enterprises, Inc., DBA Gordon Laboratories
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
cGMP Deviations
Class II