Drug Recalls
RSS ↗2,051 drug recalls from federal enforcement feeds.
Showing 151–200 of 2,051
- Class II
Drug Recall · July 13, 2026
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., BrocktonPresence of Precipitate: medication was crystallizing and particles floating in the bottle
- Class II
Drug Recall · July 9, 2026
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsLack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
- Class II
Drug Recall · July 8, 2026
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- Class III
Drug Recall · July 6, 2026
Supernus Pharmaceuticals, Inc.
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., RFailed Dissolution Specifications
- Class II
Drug Recall · July 6, 2026
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-Lack of Assurance of Sterility
- Class II
Drug Recall · July 2, 2026
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-Presence of precipitate
- Class I
Drug Recall · July 1, 2026
Victory Medical Center Pharmacy
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Class III
Drug Recall · June 30, 2026
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- Class III
Drug Recall · June 30, 2026
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- Class II
Drug Recall · June 29, 2026
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, WarrencGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Class II
Drug Recall · June 29, 2026
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, WarrencGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Class II
Drug Recall · June 29, 2026
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, WarrencGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Class II
Drug Recall · June 26, 2026
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett CompaLabeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
- Class II
Drug Recall · June 26, 2026
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.Presence of Foreign Tablets/Capsules
- Class II
Drug Recall · June 25, 2026
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, WoonsockSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First ASubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest ProducSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MOSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 25, 2026
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Class II
Drug Recall · June 24, 2026
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.Failed Impurities/Degradation Specifications
- Class II
Drug Recall · June 24, 2026
Reliance Life Sciences Private Limited
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069Lack of Sterility Assurance
- Class I
Drug Recall · June 24, 2026
JB Chemicals and Pharmaceuticals Ltd
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: RiCross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
- Class II
Drug Recall · June 24, 2026
Reliance Life Sciences Private Limited
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01Lack of Sterility Assurance
- Class II
Drug Recall · June 24, 2026
Reliance Life Sciences Private Limited
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01Lack of Sterility Assurance
- Class II
Drug Recall · June 24, 2026
Reliance Life Sciences Private Limited
Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01Lack of Sterility Assurance
- Class II
Drug Recall · June 23, 2026
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, ManuCGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
- Class II
Drug Recall · June 23, 2026
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Class II
Drug Recall · June 22, 2026
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Class II
Drug Recall · June 17, 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
- Class II
Drug Recall · June 12, 2026
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05Crystallization; identified as Buprenorphine free base
- Class II
Drug Recall · June 12, 2026
Boehringer Ingelheim Pharmaceuticals, Inc.
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., RidgCGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
- Class II
Drug Recall · June 11, 2026
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mLLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel