FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

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 1181–1200 of 17,683 recalls

Class IITerminated

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc.

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

October 23, 2024 · DrugView details →

Class IIOngoing

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

Cipla USA, Inc.

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

October 23, 2024 · DrugView details →

Class IIOngoing

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90

Cipla USA, Inc.

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

October 23, 2024 · DrugView details →

Class IIOngoing

Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specification

October 22, 2024 · DrugView details →

Class IIOngoing

Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specification

October 22, 2024 · DrugView details →

Class IITerminated

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

BLI International, Inc.

Superpotent Drug: Stability failure for assay at 6 months test time-point.

October 21, 2024 · DrugView details →

Class IIOngoing

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

AvKARE

Labeling: Label Mix-Up

October 18, 2024 · DrugView details →

Class IIOngoing

Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28

AvKARE

Labeling: Label Mix-Up

October 18, 2024 · DrugView details →

Class IIOngoing

Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10

Keystone Industries

Subpotent Drug

October 17, 2024 · DrugView details →

Class IIOngoing

OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.

Akron Pharma, Inc.

CGMP Deviations

October 15, 2024 · DrugView details →

Class IIITerminated

Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

Padagis US LLC

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

October 11, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

ACCORD HEALTHCARE, INC.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

October 10, 2024 · DrugView details →

Class IICompleted

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

Breckenridge Pharmaceutical, Inc

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

October 10, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

ACCORD HEALTHCARE, INC.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

October 10, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

ACCORD HEALTHCARE, INC.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

October 10, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

October 9, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

October 9, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

October 9, 2024 · DrugView details →

Class IIOngoing

LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01

Neogen Corporation

CGMP violations.

October 8, 2024 · DrugView details →

Class IIOngoing

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

C & A Naturistics

Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

October 8, 2024 · DrugView details →

← PreviousPage 60 of 885Next →