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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

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · DrugView details →

Class IIITerminated

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · Drug

View details →

Class IIITerminated

Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · DrugView details →

Class IIITerminated

Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · DrugView details →

Class IIITerminated

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

American Health Packaging

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

May 3, 2022 · DrugView details →

Class IIITerminated

Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2

Apotex Corp.

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

May 3, 2022 · DrugView details →

Class IIITerminated

Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388

Eco Lips, Inc

Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.

April 29, 2022 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86

SUN PHARMACEUTICAL INDUSTRIES INC

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

April 29, 2022 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India

SUN PHARMACEUTICAL INDUSTRIES INC

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

April 29, 2022 · DrugView details →

Class IIITerminated

Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5

Bestco LLC

Subpotent drug: Low OOS for menthol content at the three month room temperature.

April 27, 2022 · DrugView details →

Class IIITerminated

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

Akorn, Inc.

Failed viscosity specification - product was below specificcation

April 15, 2022 · DrugView details →

Class IIITerminated

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

Monarch PCM, LLC

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

April 14, 2022 · DrugView details →

Class IIITerminated

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

April 13, 2022 · DrugView details →

Class IIITerminated

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59

American Health Packaging

Subpotent Drug: Out of specification for assay.

April 12, 2022 · DrugView details →

Class IIITerminated

Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.

Aurobindo Pharma USA Inc.

Subpotent Drug: Out of Specification results for Assay

April 5, 2022 · DrugView details →

Class IIITerminated

Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06

Jubilant Cadista Pharmaceuticals, Inc.

Subpotent

April 1, 2022 · DrugView details →

Class IIITerminated

23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0

The Ritedose Corporation

Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.

April 1, 2022 · DrugView details →

Class IIITerminated

Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96

SUN PHARMACEUTICAL INDUSTRIES INC

Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.

April 1, 2022 · DrugView details →

Class IIITerminated

Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.

AptaPharma Inc.

Incorrect/Undeclared Excipient: Product contains alcohol

March 29, 2022 · DrugView details →

Class IIITerminated

NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40

Advanced Accelerator Applications USA, Inc.

Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

March 18, 2022 · DrugView details →

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