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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 5,381–5,400 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass III

Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15

by Nomax Inc

Reason
Subpotent Drug
Recall initiated
April 13, 2021
Reported by FDA
May 26, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

by KVK-Tech, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 27, 2021
Reported by FDA
May 26, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1

by Preferred Pharmaceuticals, Inc.

Reason
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Recall initiated
April 28, 2021
Reported by FDA
May 26, 2021
Distribution
Distributed to two physician consignees located in FL.

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Drug Recall Terminated Historical recordClass II

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

by Pfizer Inc.

Reason
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Recall initiated
May 3, 2021
Reported by FDA
May 26, 2021
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

by Hyobin LLC

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Recall initiated
April 6, 2021
Reported by FDA
May 26, 2021
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

by Hyobin LLC

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Recall initiated
April 6, 2021
Reported by FDA
May 26, 2021
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

by Hyobin LLC

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Recall initiated
April 6, 2021
Reported by FDA
May 26, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10

by SigmaPharm Laboratories LLC

Reason
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Recall initiated
April 19, 2021
Reported by FDA
May 26, 2021
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

by SigmaPharm Laboratories LLC

Reason
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Recall initiated
April 19, 2021
Reported by FDA
May 26, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
April 26, 2021
Reported by FDA
May 26, 2021
Distribution
Product was distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
April 26, 2021
Reported by FDA
May 26, 2021
Distribution
Product was distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
April 26, 2021
Reported by FDA
May 26, 2021
Distribution
Product was distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
April 26, 2021
Reported by FDA
May 26, 2021
Distribution
Product was distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
April 26, 2021
Reported by FDA
May 26, 2021
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass I

BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38

by CareFusion 213, LLC

Reason
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Recall initiated
April 20, 2021
Reported by FDA
May 19, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of foreign substance: identified as activated carbon.
Recall initiated
May 4, 2021
Reported by FDA
May 19, 2021
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Imperial Platinum 2000, 1 capsule, UPC 718122040702

by QMart

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Recall initiated
March 31, 2021
Reported by FDA
May 12, 2021
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Burro en Primavera, 2 capsules, UPC 638632431055

by QMart

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Recall initiated
March 31, 2021
Reported by FDA
May 12, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887

by QMart

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Recall initiated
March 31, 2021
Reported by FDA
May 12, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702

by QMart

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Recall initiated
March 31, 2021
Reported by FDA
May 12, 2021
Distribution
USA 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.