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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 9701–9720 of 17,793 recalls

Class IITerminated

PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60

PD-Rx Pharmaceuticals, Inc.

CGMP deviations.

January 25, 2018 · DrugView details →
Class IIITerminated

Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205

JCB Laboratories LLC

Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.

January 24, 2018 · DrugView details →
Class IIITerminated

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653

Oxygen Development Llc

Superpotent drug: failed assay throughout the stick after 6 months stability.

January 24, 2018 · DrugView details →
Class IIITerminated

Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01

Ascent Pharmaceuticals, Inc.

Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

January 22, 2018 · DrugView details →
Class IIITerminated

Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51

AbbVie Inc.

Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

January 22, 2018 · DrugView details →
Class IITerminated

Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10

Astellas Pharma US Inc

Labeling: Label Error on Declared Strength

January 22, 2018 · DrugView details →
Class IITerminated

Ling Zhi capsules

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

TP Drug Laboratories Vitamin C ampules

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Relumins Vitamin C Solvent ampules

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IIITerminated

Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.

G & W Laboratories, Inc.

Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

January 19, 2018 · DrugView details →
Class IITerminated

Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Reiki Glutathione Whitening kits

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.

AMERICAN HEALTH PACKAGING

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

January 19, 2018 · DrugView details →
Class IITerminated

Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
Class IITerminated

Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India

Flawless Beauty LLC

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

January 19, 2018 · DrugView details →
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