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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 41–60 of 1,000 recalls

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 →

Class IIOngoing

Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.

Central Admixture Pharmacy Services, Inc.

Incorrect product formulation: bag did not contain copper and famotidine per label.

June 2, 2026 · DrugView details →

Class IIOngoing

Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIIOngoing

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

ANI Pharmaceuticals, Inc.

Presence of foreign substance

June 2, 2026 · DrugView details →

Class IIOngoing

Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

Class IIOngoing

Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →

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