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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 261–280 of 1,000 recalls

Class IIITerminated

Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8

Woodbine Products Co Inc

Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.

August 30, 2022 · DrugView details →

Class IIITerminated

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

Leading Pharma, LLC

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

August 23, 2022 · DrugView details →

Class IIIOngoing

Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24

Akorn, Inc

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

August 8, 2022 · DrugView details →

Class IIITerminated

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.

LNK International, Inc.

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

August 4, 2022 · DrugView details →

Class IIITerminated

Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

Akron Pharma, Inc.

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

August 4, 2022 · DrugView details →

Class IIITerminated

Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

Akron Pharma, Inc.

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

August 4, 2022 · DrugView details →

Class IIITerminated

Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02

HERON THERAPEUTICS, INC.

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

August 2, 2022 · DrugView details →

Class IIITerminated

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56

Amerisource Health Services LLC

Subpotent Drug

July 27, 2022 · DrugView details →

Class IIITerminated

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

Teva Pharmaceuticals USA Inc

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

July 22, 2022 · DrugView details →

Class IIITerminated

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

AVKARE Inc.

Labeling: Label Error on Declared Strength

July 20, 2022 · DrugView details →

Class IIIOngoing

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.

Glenmark Pharmaceuticals Inc., USA

Defective Container: Tube split from side seam

July 11, 2022 · DrugView details →

Class IIICompleted

Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.

The Procter & Gamble Company

Labeling: Missing label: the product tube was missing a label and contained a different formulation.

July 8, 2022 · DrugView details →

Class IIIOngoing

Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.

Glenmark Pharmaceuticals Inc., USA

Failed Tablet/Capsule Specification : Capsule breakage

June 29, 2022 · DrugView details →

Class IIITerminated

Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Eco Lips, Inc

Failed Dissolution Specifications

June 29, 2022 · DrugView details →

Class IIITerminated

Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Eco Lips, Inc

Failed Dissolution Specifications

June 29, 2022 · DrugView details →

Class IIITerminated

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

June 21, 2022 · DrugView details →

Class IIITerminated

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

June 21, 2022 · DrugView details →

Class IIITerminated

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Defective Container

June 16, 2022 · DrugView details →

Class IIITerminated

Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01

Teva Pharmaceuticals USA Inc

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

May 18, 2022 · DrugView details →

Class IIITerminated

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

GlaxoSmithKline LLC

Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

May 13, 2022 · DrugView details →

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