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FDA Drug Recalls

676 recalls · Class II, newest first

Class II · Moderate risk Ongoing Sep 26, 2025

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or…

Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

Dr. Reddy's Laboratories, Inc. D-0008-2026

Class II · Moderate risk Ongoing Sep 25, 2025

Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden…

Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.

SV Labs Prescott Corporation D-0022-2026

Class II · Moderate risk Ongoing Sep 24, 2025

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…

Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Zydus Pharmaceuticals (USA) Inc NDC 68382-921-06 D-0002-2026

Class II · Moderate risk Ongoing Sep 24, 2025

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…

Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Zydus Pharmaceuticals (USA) Inc NDC 68382-920-06 D-0001-2026

Class II · Moderate risk Ongoing Sep 23, 2025

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave…

Reason CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Park Avenue Compounding NDC 83863-4272-1 D-0178-2026

Class II · Moderate risk Ongoing Sep 23, 2025

Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview…

Reason Product Mix-up

Acme United Corporation D-0122-2026

Class II · Moderate risk Terminated Sep 22, 2025

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only…

Reason Lack of assurance of sterility.

RC Outsourcing, LLC D-0003-2026

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-514-90 D-0020-2026

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c)…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-512-90 D-0019-2026

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c)…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-513-90 D-0018-2026

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05)…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-511-90 D-0017-2026

Class II · Moderate risk Ongoing Sep 17, 2025

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez…

Reason CGMP Deviations: Market complaints received for gritty texture (grainy)

Glenmark Pharmaceuticals Inc., USA NDC 68462-626-52 D-0662-2025

Class II · Moderate risk Ongoing Sep 17, 2025

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO…

Reason CGMP Deviations

Park Avenue Compounding NDC 83863-0104-1 D-0200-2026

Class II · Moderate risk Ongoing Sep 16, 2025

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc…

Reason Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved…

Accord Healthcare, INC. NDC 16729-450-15 D-0006-2026

Class II · Moderate risk Ongoing Sep 15, 2025

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health…

Reason Failed Dissolution Specifications.

Amerisource Health Services LLC NDC 60687-594-21 D-0675-2025

Class II · Moderate risk Ongoing Sep 15, 2025

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals…

Reason Failed Tablet/Capsule Specifications

Graviti Pharmaceuticals Private Limited NDC 16571-863-03 D-0037-2026

Class II · Moderate risk Ongoing Sep 12, 2025

edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.

Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…

Private Label Skin Care Inc. D-0668-2025

Class II · Moderate risk Ongoing Sep 12, 2025

Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave…

Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…

Private Label Skin Care Inc. D-0667-2025

Class II · Moderate risk Ongoing Sep 12, 2025

mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210

Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…

Private Label Skin Care Inc. D-0666-2025

Class II · Moderate risk Ongoing Sep 12, 2025

Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com

Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…

Private Label Skin Care Inc. D-0665-2025

Class II · Moderate risk Ongoing Sep 12, 2025

Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills…

Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…

Private Label Skin Care Inc. D-0664-2025

Class II · Moderate risk Ongoing Sep 12, 2025

ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210

Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…

Private Label Skin Care Inc. D-0663-2025

Class II · Moderate risk Ongoing Sep 12, 2025

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed…

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7133-61 D-0013-2026

Class II · Moderate risk Ongoing Sep 12, 2025

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed…

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7132-61 D-0012-2026

Class II · Moderate risk Ongoing Sep 12, 2025

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed…

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7131-61 D-0011-2026