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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 261–280 of 18,048 recalls

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.

ACCORD HEALTHCARE, INC.

Subpotent Drug

June 8, 2026 · DrugView details →

Class IIOngoing

Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.

Asclemed USA Inc.

Lack of Assurance of Sterility

June 8, 2026 · DrugView details →

Class IIOngoing

Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31

ONESOURCE SPECIALTY PHARMA LIMITED

Failed Impurities/Degradation Specifications

June 7, 2026 · DrugView details →

Class IIOngoing

Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10

Inventia Healthcare Limited

Failed Dissolution Specifications

June 5, 2026 · DrugView details →

Class IIOngoing

Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.

Annora Pharma Private Limited

Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

June 4, 2026 · DrugView details →

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

Haleon US Holdings LLC

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

June 4, 2026 · DrugView details →

Class IIOngoing

Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60

Amgen, Inc.

Presence of Foreign Substance.

June 4, 2026 · DrugView details →

Class IIOngoing

Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.

Amgen, Inc.

Presence of Foreign Substance.

June 4, 2026 · DrugView details →

Class IIOngoing

Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30

Amgen, Inc.

CGMP Deviations

June 4, 2026 · DrugView details →

Class IIOngoing

Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.

Elevate Oral Care

sub potency

June 4, 2026 · DrugView details →

Class IIOngoing

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA

Lupin Pharmaceuticals Inc.

Presence of Foreign Substance

June 4, 2026 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

June 4, 2026 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

June 4, 2026 · DrugView details →

Class IIOngoing

Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30

Amgen, Inc.

CGMP Deviations

June 4, 2026 · DrugView details →

Class IIOngoing

Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30

Amgen, Inc.

CGMP Deviations

June 4, 2026 · DrugView details →

Class IIIOngoing

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01

Amneal Pharmaceuticals, LLC

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

June 3, 2026 · DrugView details →

Class IIOngoing

Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

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