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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

Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63

SV Labs Toronto Corporation

Microbial contamination of topical product.

September 1, 2026 · DrugView details →

Class IIOngoing

Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.

TerSera Therapeutics LLC

Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

August 31, 2026 · DrugView details →

Class IIOngoing

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5

SUN PHARMA /TARO

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

August 31, 2026 · DrugView details →

Class IIOngoing

Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1

Amneal Pharmaceuticals of New York, LLC

Defective Delivery System: Possibility of no medication in the prefilled pen.

August 28, 2026 · DrugView details →

Class IIOngoing

Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.

Mylan Pharmaceuticals Inc

Failed Dissolution Specifications

August 26, 2026 · DrugView details →

Class IIOngoing

Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.

Hikma Pharmaceuticals USA INC.

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

August 24, 2026 · DrugView details →

Class IIOngoing

traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01

Teva Pharmaceuticals USA, Inc

Presence of Foreign Tablets/Capsules

August 24, 2026 · DrugView details →

Class IIOngoing

Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7

Lexia LLC

CGMP Deviations: Potential contamination of raw material

August 21, 2026 · DrugView details →

Class IIOngoing

Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4

Lexia LLC

CGMP Deviations: Potential contamination of raw material

August 21, 2026 · DrugView details →

Class IIOngoing

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.

Golden State Medical Supply Inc.

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

August 21, 2026 · DrugView details →

Class IIOngoing

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.

Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

August 20, 2026 · DrugView details →

Class IIOngoing

2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26

Sage Products, LLC

Cross Contamination with Other Products

August 18, 2026 · DrugView details →

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