Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
May 10, 2024
Preferred Pharmaceuticals, Inc
66 bottles of 30 tablets units
FDA Drug
Class III
Ongoing
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactu
May 10, 2024
Bryant Ranch Prepack Inc.
6 bottles units
FDA Drug
Class III
Ongoing
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabele
May 10, 2024
Bryant Ranch Prepack Inc.
190 bottles units
FDA Drug
Class II
Ongoing
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
May 10, 2024
Glenmark Pharmaceuticals Inc., USA
3,480 cartons units
FDA Drug
Class II
Terminated
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 0
May 8, 2024
Lupin Pharmaceuticals Inc.
51,006 bottles units
FDA Drug
Class II
Ongoing
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-
May 7, 2024
Pacira Pharmaceuticals, Inc.
43,768 kits units
FDA Drug
Class II
Ongoing
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
May 7, 2024
Macleods Pharma Usa Inc
1,048 bottles units
FDA Drug
Class II
Ongoing
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
May 6, 2024
Rubicon Research Private Limited
11,664 Bottles units
FDA Drug
Class II
Terminated
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
May 2, 2024
RemedyRepack Inc.
23,970 Tablets units
FDA Drug
Class II
Ongoing
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.
May 1, 2024
Pharma Nobis LLC
120830 units
FDA Drug
Class II
Ongoing
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
May 1, 2024
Pharma Nobis LLC
24840 units
FDA Drug
Class III
Ongoing
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
May 1, 2024
Dr. Reddy's Laboratories, Inc.
1,176 bottles units
FDA Drug
Class II
Completed
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
April 30, 2024
Viatris Inc
12,691 bottles units
FDA Drug
Class II
Completed
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
April 30, 2024
Viatris Inc
3,694 bottles units
FDA Drug
Class III
Completed
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
April 30, 2024
Hikma Injectables USA Inc
1,895 bags units
FDA Drug
Class II
Ongoing
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.,
April 29, 2024
Breckenridge Pharmaceutical, Inc
7,188/ 500 count bottles units
FDA Drug
Class II
Ongoing
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
April 29, 2024
Breckenridge Pharmaceutical, Inc
281,554/90 & 1000 count bottles units
FDA Drug
Class II
Ongoing
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
April 29, 2024
Breckenridge Pharmaceutical, Inc
281,554/90 count bottles units
FDA Drug
Class I
Completed
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
April 29, 2024
Hikma Injectables USA Inc
FDA Drug
Class II
Ongoing
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
April 26, 2024
Rubicon Research Private Limited
2,592 1000-count Bottles units
FDA Drug
Class III
Completed
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
April 25, 2024
Viatris Inc
143,230 bottles units
FDA Drug
Class II
Completed
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
April 25, 2024
FDC Limited
382,104 units units
FDA Drug
Class II
Ongoing
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:
April 25, 2024
Sagent Pharmaceuticals
14,360 vials units
FDA Drug
Class II
Terminated
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
April 24, 2024
Lupin Pharmaceuticals Inc.
17,040 bottles units
FDA Drug
Class II
Completed
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.
April 24, 2024
Coast Quality Pharmacy, LLC dba Anazao Health
9896 tablets units
FDA Drug
Class III
Terminated
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
April 24, 2024
Acella Pharmaceuticals, LLC
7104 Bottles units
FDA Drug
Class II
Ongoing
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
April 24, 2024
Aurobindo Pharma USA Inc
6696 bottles units
FDA Drug
Class II
Terminated
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
April 24, 2024
Lupin Pharmaceuticals Inc.
17,070 bottles units
FDA Drug
Class II
Ongoing
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,
April 24, 2024
SOMERSET THERAPEUTICS LLC
5,578 units units
FDA Drug
Class II
Ongoing
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
April 24, 2024
Aurobindo Pharma USA Inc
6909 bottles units
FDA Drug
Class II
Terminated
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,
April 23, 2024
EPI Health, LLC
12808 bottles units
FDA Drug
Class II
Terminated
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,
April 23, 2024
Regeneron Pharmaceuticals Inc
251,504 syringes units
FDA Drug
Class II
Terminated
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
April 23, 2024
EPI Health, LLC
18645 tubes units
FDA Drug
Class II
Terminated
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,
April 23, 2024
EPI Health, LLC
5664 bottles units
FDA Drug
Class I
Terminated
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
April 22, 2024
Stop Clopez Corp
5 boxes units
FDA Drug
Class III
Ongoing
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
April 22, 2024
Sun Pharmaceutical Industries Inc.
35,069 bottles units
FDA Drug
Class I
Ongoing
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
April 20, 2024
Revive Rx LLC dba Revive Rx Pharmacy
751 vials units
FDA Drug
Class II
Ongoing
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.
April 19, 2024
Nomax Inc
4648 cartons units
FDA Drug
Class II
Ongoing
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.
April 19, 2024
Nomax Inc
6,960 cartons units
FDA Drug
Class II
Ongoing
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
April 19, 2024
Sun Pharmaceutical Industries Inc.
11,016 vials units
FDA Drug
Class II
Ongoing
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
April 19, 2024
Nomax Inc
15,056 cartons units
FDA Drug
Class II
Ongoing
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.
April 19, 2024
Nomax Inc
15,444 cartons units
FDA Drug
Class II
Ongoing
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
April 17, 2024
ARG Laboratories, Inc.
9,697 units
FDA Drug
Class II
Ongoing
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
April 17, 2024
ARG Laboratories, Inc.
7,410 units
FDA Drug
Class II
Ongoing
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
April 17, 2024
Glenmark Pharmaceuticals Inc., USA
3,264 bottles units
FDA Drug
Class II
Ongoing
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
April 17, 2024
ARG Laboratories, Inc.
6,264 units
FDA Drug
Class II
Ongoing
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
April 17, 2024
ARG Laboratories, Inc.
4,013 units
FDA Drug
Class II
Ongoing
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
April 17, 2024
ARG Laboratories, Inc.
3,440 units
FDA Drug
Class II
Ongoing
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
April 17, 2024
ARG Laboratories, Inc.
3,000 units
FDA Drug
Class II
Ongoing
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
April 17, 2024
ARG Laboratories, Inc.
1,680 units