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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 41–60 of 65 recalls

Class IIIOngoing

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.

Glenmark Pharmaceuticals Inc., USA

Cross Contamination with Other Products

November 18, 2025 · DrugView details →
Class IIIOngoing

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Dr. Reddy's Laboratories, Inc.

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

November 11, 2025 · DrugView details →
Class IIIOngoing

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

Teva Pharmaceuticals USA, Inc

Defective Container - A defect in the side-seal which allows leakage of product.

November 7, 2025 · DrugView details →
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 →
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