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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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Drug Recall Terminated Historical recordClass II

Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03

by US Pharmaceuticals Inc.

Reason: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recall initiated: December 7, 2018
Reported by FDA: February 13, 2019
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22

by US Pharmaceuticals Inc.

Reason: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recall initiated: December 7, 2018
Reported by FDA: February 13, 2019
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.

by Mylan Pharmaceuticals Inc.

Reason: Defective Container: Potential for broken glass in the neck area of the glass bottles.
Recall initiated: February 1, 2019
Reported by FDA: February 13, 2019
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.

by Mylan Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Recall initiated: January 18, 2019
Reported by FDA: February 6, 2019
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Recall initiated: January 9, 2019
Reported by FDA: February 6, 2019
Distribution: Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.

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Drug Recall Terminated Historical recordClass II

BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41

by Sun Pharmaceutical Industries, Inc.

Reason: Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Recall initiated: January 24, 2019
Reported by FDA: February 6, 2019
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00

by Duren Health Mart Pharmacy

Reason: Lack of Processing Controls.
Recall initiated: December 17, 2018
Reported by FDA: February 6, 2019
Distribution: TN only

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Drug Recall Terminated Historical recordClass II

Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01

by Duren Health Mart Pharmacy

Reason: Lack of Processing Controls.
Recall initiated: December 17, 2018
Reported by FDA: February 6, 2019
Distribution: TN only

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Drug Recall Terminated Historical recordClass II

Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03

by Duren Health Mart Pharmacy

Reason: Lack of Processing Controls.
Recall initiated: December 17, 2018
Reported by FDA: February 6, 2019
Distribution: TN only

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Drug Recall Terminated Historical recordClass II

Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98

by Duren Health Mart Pharmacy

Reason: Lack of Processing Controls.
Recall initiated: December 17, 2018
Reported by FDA: February 6, 2019
Distribution: TN only

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Drug Recall Terminated Historical recordClass II

Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99

by Duren Health Mart Pharmacy

Reason: Lack of Processing Controls.
Recall initiated: December 17, 2018
Reported by FDA: February 6, 2019
Distribution: TN only

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Drug Recall Terminated Historical recordClass II

Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07

by Duren Health Mart Pharmacy

Reason: Lack of Processing Controls.
Recall initiated: December 17, 2018
Reported by FDA: February 6, 2019
Distribution: TN only

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Drug Recall Terminated Historical recordClass II

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

by H J Harkins Company Inc dba Pharma Pac

Reason: Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Recall initiated: October 18, 2018
Reported by FDA: February 6, 2019
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10

by Akorn, Inc.

Reason: Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Recall initiated: October 8, 2018
Reported by FDA: February 6, 2019
Distribution: Nationwide USA and Puerto Rico

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Drug Recall Completed Historical recordClass II

Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03

by Prinston Pharmaceutical Inc

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated: January 18, 2019
Reported by FDA: February 6, 2019
Distribution: Nationwide

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Drug Recall Completed Historical recordClass II

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09

by Prinston Pharmaceutical Inc

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated: January 18, 2019
Reported by FDA: February 6, 2019
Distribution: Nationwide

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Drug Recall Completed Historical recordClass II

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03

by Prinston Pharmaceutical Inc

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated: January 18, 2019
Reported by FDA: February 6, 2019
Distribution: Nationwide

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Drug Recall Completed Historical recordClass II

Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09

by Prinston Pharmaceutical Inc

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated: January 18, 2019
Reported by FDA: February 6, 2019
Distribution: Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09

by Prinston Pharmaceutical Inc

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated: January 18, 2019
Reported by FDA: February 6, 2019
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65

by Advanced Pharma Inc.

Reason: Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Recall initiated: January 15, 2019
Reported by FDA: January 30, 2019
Distribution: TX, WA

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Data last updated: September 22, 2026 ET

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.