Drugs Recalls

17,415 recalls in this category

FDA Drug Class II Ongoing

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 In

March 7, 2025 Mylan Institutional Inc 1,068 cartons units
FDA Drug Class II Ongoing

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

March 7, 2025 Slate Run Pharmaceuticals 2,444 bottles units
FDA Drug Class II Ongoing

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 Ind

March 7, 2025 Mylan Institutional Inc 347 Cartons units
FDA Drug Class II Ongoing

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

March 7, 2025 Slate Run Pharmaceuticals 56,790 bottles units
FDA Drug Class II Ongoing

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For I

March 6, 2025 QuVa Pharma, Inc. 2,310 cassettes units
FDA Drug Class II Ongoing

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Instit

March 6, 2025 QuVa Pharma, Inc. N/A units
FDA Drug Class II Ongoing

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Instit

March 6, 2025 QuVa Pharma, Inc. 1,765 cassettes units
FDA Drug Class II Ongoing

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

March 5, 2025 Strides Pharma INC 195,952 Cartons; 30 sachets/Carton. units
FDA Drug Class II Ongoing

Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

March 5, 2025 Strides Pharma INC 244,412 Cartons; 30 sachets /Carton units
FDA Drug Class II Ongoing

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40

March 5, 2025 L'Oreal USA
FDA Drug Class II Ongoing

La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube,

March 5, 2025 L'Oreal USA 14,460 bottles units
FDA Drug Class II Ongoing

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New

March 5, 2025 L'Oreal USA 2,226,801 bottles units
FDA Drug Class II Ongoing

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

March 5, 2025 Golden State Medical Supply Inc. 2,601 30-count bottles units
FDA Drug Class II Ongoing

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

March 5, 2025 Rising Pharma Holding, Inc. 1223 bottles units
FDA Drug Class II Ongoing

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. Bo

March 4, 2025 Chattem Inc 180,696 cartons units
FDA Drug Class III Ongoing

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ

March 4, 2025 Sun Pharmaceutical Industries Inc. 852 bottles units
FDA Drug Class III Terminated

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.

March 4, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 224 cartons units
FDA Drug Class III Ongoing

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ

March 4, 2025 Sun Pharmaceutical Industries Inc. 12,876 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

February 28, 2025 Glenmark Pharmaceuticals Inc., USA 18,696 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

February 28, 2025 Glenmark Pharmaceuticals Inc., USA 84,048 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Gle

February 28, 2025 Glenmark Pharmaceuticals Inc., USA [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Phar

February 28, 2025 Glenmark Pharmaceuticals Inc., USA [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles units
FDA Drug Class II Ongoing

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., Ber

February 28, 2025 Breckenridge Pharmaceutical, Inc 11,125 bottles. units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Be

February 28, 2025 Breckenridge Pharmaceutical, Inc 14,749 bottles. units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Be

February 28, 2025 Breckenridge Pharmaceutical, Inc 11,100 bottles. units
FDA Drug Class II Ongoing

Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8

February 28, 2025 Sigan Industries Group Inc. 13,440 tubes units
FDA Drug Class II Ongoing

Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, ND

February 27, 2025 Amgen, Inc. 313,620 Vials units
FDA Drug Class II Ongoing

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

February 27, 2025 Amgen, Inc. 258,750 Vials units
FDA Drug Class II Ongoing

METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

February 25, 2025 A-S Medication Solutions LLC. 411 180-count bottles units
FDA Drug Class II Ongoing

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93

February 25, 2025 Mylan Pharmaceuticals Inc. N/A units
FDA Drug Class III Completed

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 Pharmaceutica

February 24, 2025 Kowa Pharmaceuticals America 5,328 Bottles units
FDA Drug Class II Ongoing

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

February 24, 2025 Denison Pharmaceuticals, LLC 642,131 tubes units
FDA Drug Class III Ongoing

Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, ND

February 24, 2025 Imprimis NJOF, LLC 2822 bottles units
FDA Drug Class I Ongoing

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 7

February 20, 2025 Central Admixture Pharmacy Services, Inc. 1546 bags units
FDA Drug Class I Ongoing

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

February 20, 2025 One Source Nutrition, Inc, a) 300 individually wrapped capsules b) 20 bottles units
FDA Drug Class II Completed

Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Driv

February 18, 2025 Turbare Manufacturing 1,147 syringes units
FDA Drug Class II Ongoing

Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 6936702

February 17, 2025 Safecor Health, LLC 3069 Oral Syringes units
FDA Drug Class II Ongoing

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

February 17, 2025 MEDLINE INDUSTRIES, LP - Northfield 1,639,996 pads units
FDA Drug Class II Ongoing

Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001,

February 17, 2025 Safecor Health, LLC 3465 Oral Syringes units
FDA Drug Class II Ongoing

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 6961800705

February 17, 2025 Safecor Health, LLC 1535 Oral Syringes units
FDA Drug Class II Ongoing

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,

February 17, 2025 MEDLINE INDUSTRIES, LP - Northfield 6,669,874 pads units
FDA Drug Class II Ongoing

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054

February 17, 2025 Safecor Health, LLC 12390 Oral Syringes units
FDA Drug Class II Ongoing

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

February 17, 2025 Safecor Health, LLC 10992 Oral Syringes units
FDA Drug Class I Ongoing

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Appl

February 14, 2025 Carefusion 213, Llc 205,440 applicators units
FDA Drug Class II Ongoing

Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 7

February 13, 2025 World Perfumes Inc. 3,900 bottles units
FDA Drug Class II Ongoing

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 813

February 13, 2025 Johnson, S C and Son, Inc 493,462 units units
FDA Drug Class I Ongoing

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

February 13, 2025 ICU Medical Inc unknown units
FDA Drug Class II Ongoing

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd,

February 13, 2025 Zydus Pharmaceuticals USA Inc 1,893 vials units
FDA Drug Class I Ongoing

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (

February 13, 2025 ICU Medical Inc 67,488 flexible containers units
FDA Drug Class II Ongoing

Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930;

February 13, 2025 Johnson, S C and Son, Inc 449,502 units units

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