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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 1–20 of 1,000 recalls

Class IITerminated

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

RC Outsourcing, LLC

Lack of assurance of sterility.

September 22, 2025 · DrugView details →

Class IITerminated

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

Lannett Company Inc.

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

August 11, 2025 · DrugView details →

Class IITerminated

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.

Lupin Pharmaceuticals Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

July 2, 2025 · DrugView details →

Class IITerminated

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

June 27, 2025 · DrugView details →

Class IITerminated

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

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