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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 701–720 of 1,000 recalls

Class IIIOngoing

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

Qualgen, LLC

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

June 16, 2025 · DrugView details →
Class IIOngoing

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

June 16, 2025 · DrugView details →
Class IIOngoing

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.

B BRAUN MEDICAL INC

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

June 16, 2025 · DrugView details →
Class IIIOngoing

Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.

Orient Pharma Co., Ltd. Yunlin Plant

Failed Impurities/Degradation Specifications.

June 11, 2025 · DrugView details →
Class IIIOngoing

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.

Macleods Pharmaceuticals Ltd

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

June 11, 2025 · DrugView details →
Class IIIOngoing

Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.

Orient Pharma Co., Ltd. Yunlin Plant

Failed Impurities/Degradation Specifications.

June 11, 2025 · DrugView details →
Class IIOngoing

KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026

IMMUNOCORE, LLC

Subpotent Drug

June 10, 2025 · DrugView details →
Class IOngoing

Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.

Church & Dwight Inc

Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.

June 6, 2025 · DrugView details →
Class IOngoing

ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5

Church & Dwight Inc

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

June 6, 2025 · DrugView details →
Class IOngoing

ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6

Church & Dwight Inc

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

June 6, 2025 · DrugView details →
Class IIOngoing

KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →
Class IIOngoing

LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →
Class IIOngoing

KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →
Class IIOngoing

BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →
Class IIOngoing

LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →
Class IOngoing

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Amneal Pharmaceuticals, LLC

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

June 2, 2025 · DrugView details →
Class IIOngoing

LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.

Tailstorm Health INC

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

June 2, 2025 · DrugView details →
Class IIOngoing

Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.

Zydus Pharmaceuticals (USA) Inc

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

May 30, 2025 · DrugView details →
Class IIOngoing

TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01

Advanced Pharmaceutical Technology, Inc.

Marketed Without an Approved NDA/ANDA

May 30, 2025 · DrugView details →
Class IIOngoing

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25

Eugia US LLC

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

May 29, 2025 · DrugView details →
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