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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 156 recalls

Class IIIOngoing

Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05

Imprimis NJOF, LLC

Subpotent Drug

October 20, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

Class IIIOngoing

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

Alembic Pharmaceuticals Limited

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

October 10, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

Class IIIOngoing

Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.

STAQ Pharma, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date

October 9, 2025 · DrugView details →

Class IIIOngoing

Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.

STAQ Pharma, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date

October 9, 2025 · DrugView details →

Class IIIOngoing

FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.

STAQ Pharma, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date

October 9, 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 IIIOngoing

Cetirizine Hydrochloride Tablets USP 10 mg, 500 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 16571-402-50

JB Chemicals and Pharmaceuticals Ltd

Tablet/Capsules Imprinted with Wrong ID

September 12, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

September 5, 2025 · DrugView details →

Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →

Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →

Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →

Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →

Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →

Class IIIOngoing

TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14

Consumer Product Partners, LLC

Cross Contamination with Other Products.

August 25, 2025 · DrugView details →

Class IIIOngoing

Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14

Consumer Product Partners, LLC

Cross Contamination with Other Products.

August 25, 2025 · DrugView details →

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