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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 201–220 of 718 recalls

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61

Major Pharmaceuticals

Subpotent Drug

July 13, 2026 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61

Major Pharmaceuticals

Subpotent Drug

July 13, 2026 · DrugView details →

Class IIOngoing

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., Brockton, MA. NDC 64980-504-48.

Rising Pharma Holding, Inc.

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

July 13, 2026 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61

Major Pharmaceuticals

Subpotent Drug

July 13, 2026 · DrugView details →

Class IIOngoing

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, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31

CareFusion 213, LLC

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

July 9, 2026 · DrugView details →

Class IIOngoing

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 07054. NDC: 67877-500-30

Ascend Laboratories, LLC

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

July 8, 2026 · DrugView details →

Class IIOngoing

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 10122-611-10.

Chiesi USA, Inc.

Lack of Assurance of Sterility

July 6, 2026 · DrugView details →

Class IIIOngoing

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., Rockville, MD 20850 USA, NDC 17772-101-30.

Supernus Pharmaceuticals, Inc.

Failed Dissolution Specifications

July 6, 2026 · DrugView details →

Class IIOngoing

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 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).

MYLAN PHARMACEUTICALS INC

Presence of precipitate

July 2, 2026 · DrugView details →

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.

Victory Medical Center Pharmacy

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

July 1, 2026 · DrugView details →

Class IIIOngoing

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 0904-7255-10.

Ascend Laboratories, LLC

Failed 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.

June 30, 2026 · DrugView details →

Class IIIOngoing

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 0904-7254-68.

Ascend Laboratories, LLC

Failed 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.

June 30, 2026 · DrugView details →

Class IIOngoing

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, Warren, NJ 07059, NDC 69097-410-02

Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

June 29, 2026 · DrugView details →

Class IIOngoing

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, Warren, NJ 07059, NDC 69097-412-02

Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

June 29, 2026 · DrugView details →

Class IIOngoing

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, Warren, NJ 07059, NDC 69097-411-02

Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

June 29, 2026 · DrugView details →

Class IIOngoing

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.

Bionpharma Inc.

Presence of Foreign Tablets/Capsules

June 26, 2026 · DrugView details →

Class IIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.

Lannett Company Inc.

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

June 26, 2026 · DrugView details →

Class IIOngoing

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, MI 48376.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

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 Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

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.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

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