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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 9,521–9,540 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.

by Shadow Holdings DBA Bocchi Labs

Reason
CGMP Deviations: products may be contaminated with bacteria.
Recall initiated
May 25, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58.

by Medline Industries Inc (Northpoint Services)

Reason
Microbial Contamination of a Non-Sterile Product.
Recall initiated
May 22, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the U.S. and Qatar.

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ

by PharMEDium Services, LLC

Reason
Superpotent and Subpotent
Recall initiated
June 5, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123

by RIJ Pharmaceutical LLC

Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Recall initiated
May 7, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL

by HOSPIRA INC, LAKE FOREST

Reason
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Recall initiated
June 4, 2018
Reported by FDA
June 13, 2018
Distribution
Nationwide in the U.S., Puerto Rico, and Guam

View recall →

Drug Recall Terminated Historical recordClass III

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Recall initiated
May 25, 2018
Reported by FDA
June 13, 2018
Distribution
IN, MI, MS, NC, NJ, NY and OH

View recall →

Drug Recall Terminated Historical recordClass III

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

by Pharmaceutical Associates Inc

Reason
Resuspension problems: Out of specification for appearance and resuspendability.
Recall initiated
May 29, 2018
Reported by FDA
June 13, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1

by Apotex Inc.

Reason
Presence of foreign substance: glass particles
Recall initiated
May 31, 2018
Reported by FDA
June 13, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148

by Shoreside Enterprises Inc.

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Recall initiated
May 17, 2018
Reported by FDA
June 6, 2018
Distribution
Nationwide.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.