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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 561–580 of 1,000 recalls

Class IITerminated

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.

SterRx, LLC

Lack of Assurance of Sterility

July 7, 2023 · DrugView details →

Class IITerminated

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

SterRx, LLC

Lack of Assurance of Sterility

July 7, 2023 · DrugView details →

Class IITerminated

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

Teva Pharmaceuticals USA Inc

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

July 5, 2023 · DrugView details →

Class IIITerminated

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

July 5, 2023 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

B. Braun Medical Inc.

Lack of assurance of sterility: bags have the potential to leak.

July 5, 2023 · DrugView details →

Class IITerminated

Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.

Accord Healthcare, Inc.

Presence of Particulate Matter: Particulate matter identified as fiber.

July 3, 2023 · DrugView details →

Class IITerminated

Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.

Accord Healthcare, Inc.

Presence of Particulate Matter: Particulate matter identified as fiber.

July 3, 2023 · DrugView details →

Class IIITerminated

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03

Lupin Pharmaceuticals Inc.

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

June 27, 2023 · DrugView details →

Class ITerminated

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

Cipla USA, Inc.

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

June 27, 2023 · DrugView details →

Class IITerminated

Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08

Strides Pharma Inc.

Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

June 26, 2023 · DrugView details →

Class ITerminated

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA

Lupin Pharmaceuticals Inc.

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

June 23, 2023 · DrugView details →

Class IITerminated

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

Kramer Laboratories, Inc.

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

June 23, 2023 · DrugView details →

Class IITerminated

Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.

Amerisource Health Services LLC

Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.

June 23, 2023 · DrugView details →

Class IITerminated

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807

Kramer Laboratories, Inc.

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

June 23, 2023 · DrugView details →

Class IITerminated

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61

The Harvard Drug Group

Packaging defect: blister packaging inadequately sealed.

June 16, 2023 · DrugView details →

Class IIITerminated

Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30

Amring Pharmaceuticals Inc

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

June 12, 2023 · DrugView details →

Class IITerminated

Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03

Ferring Pharmaceuticals Inc

cGMP deviations: potential for Microbial Contamination of Non-Sterile Products

June 12, 2023 · DrugView details →

Class IIITerminated

GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3

HF Acquisition Co LLC

Labeling: Label Mix-up

June 6, 2023 · DrugView details →

Class IITerminated

Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

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