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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 281–300 of 1,000 recalls

Class IIITerminated

Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90

Novocol Pharmaceutical of Canada, Inc.

Labeling: Label mix-up

November 20, 2020 · DrugView details →

Class IIITerminated

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

SCA Pharmaceuticals

Subpotency: Out-of-specification stability test result for low potency was obtained.

November 20, 2020 · DrugView details →

Class IIITerminated

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

Fresenius Kabi USA, LLC

Cross Contamination with Other Products: trace amounts of octreotide found during testing

November 17, 2020 · DrugView details →

Class IIITerminated

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.

Teva Pharmaceuticals USA

Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

November 11, 2020 · DrugView details →

Class IIITerminated

Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30

InvaTech Pharma Solutions, LLC

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

November 11, 2020 · DrugView details →

Class IIITerminated

Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60

Teligent Pharma, Inc.

Superpotent and Subpotent; low and high assay results

November 5, 2020 · DrugView details →

Class IIITerminated

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59

Teligent Pharma, Inc.

Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.

November 3, 2020 · DrugView details →

Class IIITerminated

Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32

Jubilant Cadista Pharmaceuticals, Inc.

Subpotent

October 26, 2020 · DrugView details →

Class IIITerminated

Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01

Heritage Pharmaceuticals Inc

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

October 23, 2020 · DrugView details →

Class IIITerminated

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92

Aurobindo Pharma USA Inc.

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

October 22, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22

eVenus Pharmaceutical Laboratories

DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.

October 6, 2020 · DrugView details →

Class IIITerminated

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Mylan Pharmaceuticals Inc.

Out-of-specification organic impurity results obtained during routine stability testing.

October 2, 2020 · DrugView details →

Class IIITerminated

Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310

Teligent Pharma, Inc.

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

September 28, 2020 · DrugView details →

Class IIITerminated

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,

VistaPharm, Inc.

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

September 25, 2020 · DrugView details →

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