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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 7,581–7,600 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Recall initiated
July 12, 2019
Reported by FDA
August 14, 2019
Distribution
Nationwide within the United States and Brazil and on the internet

View recall →

Drug Recall Terminated Historical recordClass II

Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Recall initiated
July 12, 2019
Reported by FDA
August 14, 2019
Distribution
Nationwide within the United States and Brazil and on the internet

View recall →

Drug Recall Terminated Historical recordClass II

Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Recall initiated
July 12, 2019
Reported by FDA
August 14, 2019
Distribution
Nationwide within the United States and Brazil and on the internet

View recall →

Drug Recall Terminated Historical recordClass III

Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179

by AAA Pharmaceutical, Inc.

Reason
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Recall initiated
June 25, 2019
Reported by FDA
August 14, 2019
Distribution
KS

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Drug Recall Terminated Historical recordClass III

Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.

by American Health Packaging

Reason
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Recall initiated
February 19, 2019
Reported by FDA
August 14, 2019
Distribution
Nationwide within the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass I

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Failed dissolution specifications : failed results at the 3-month stability time point.
Recall initiated
July 9, 2019
Reported by FDA
August 7, 2019
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01

by Piramal Critical Care, Inc.

Reason
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Recall initiated
July 8, 2019
Reported by FDA
August 7, 2019
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1

by LNK International, Inc.

Reason
Microbial contamination of non-sterile product
Recall initiated
July 10, 2019
Reported by FDA
August 7, 2019
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

by MAJOR PHARMACEUTICALS

Reason
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Recall initiated
April 24, 2019
Reported by FDA
August 7, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11

by American Health Packaging

Reason
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Recall initiated
August 1, 2018
Reported by FDA
August 7, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01

by H J Harkins Company Inc dba Pharma Pac

Reason
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Recall initiated
July 12, 2019
Reported by FDA
August 7, 2019
Distribution
Distributed in California

View recall →

Drug Recall Terminated Historical recordClass II

Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

by ImprimisRx NJ

Reason
Subpotent Drug
Recall initiated
July 17, 2019
Reported by FDA
August 7, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

by ImprimisRx NJ

Reason
Subpotent Drug
Recall initiated
July 17, 2019
Reported by FDA
August 7, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

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.