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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 821–840 of 18,048 recalls

Class IIOngoing

Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015

ACME UNITED CORPORATION

Product Mix-up

September 23, 2025 · DrugView details →

Class IIOngoing

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.

Park Avenue Compounding

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

September 23, 2025 · DrugView details →

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 IIOngoing

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

Ascend Laboratories, LLC

Failed Dissolution Specifications

September 19, 2025 · DrugView details →

Class IIOngoing

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Ascend Laboratories, LLC

Failed Dissolution Specifications

September 19, 2025 · DrugView details →

Class IIOngoing

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Ascend Laboratories, LLC

Failed Dissolution Specifications

September 19, 2025 · DrugView details →

Class IIOngoing

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Ascend Laboratories, LLC

Failed Dissolution Specifications

September 19, 2025 · DrugView details →

Class IIOngoing

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52

Glenmark Pharmaceuticals Inc., USA

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

September 17, 2025 · DrugView details →

Class IIOngoing

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.

Park Avenue Compounding

CGMP Deviations

September 17, 2025 · DrugView details →

Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1

IntegraDose Compounding Services LLC

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

September 16, 2025 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

ACCORD HEALTHCARE, INC.

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

September 16, 2025 · DrugView details →

Class IIOngoing

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

Graviti Pharmaceuticals Private Limited

Failed Tablet/Capsule Specifications

September 15, 2025 · DrugView details →

Class IIOngoing

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

Amerisource Health Services LLC

Failed Dissolution Specifications.

September 15, 2025 · DrugView details →

Class IIOngoing

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

Private Label Skin Care Inc.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

September 12, 2025 · DrugView details →

Class IIOngoing

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

Private Label Skin Care Inc.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

September 12, 2025 · DrugView details →

Class IIIOngoing

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.

JB Chemicals and Pharmaceuticals Ltd

Tablet/Capsules Imprinted with Wrong ID

September 12, 2025 · DrugView details →

Class IIIOngoing

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

Letco Medical LLC

Labeling: Not Elsewhere Classified

September 12, 2025 · DrugView details →

Class IIOngoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

September 12, 2025 · DrugView details →

Class IIOngoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

September 12, 2025 · DrugView details →

Class IIOngoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

September 12, 2025 · DrugView details →

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