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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 3,561–3,580 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01

by Hikma Pharmaceuticals USA Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Recall initiated
July 11, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01

by Hikma Pharmaceuticals USA Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Recall initiated
July 11, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01

by Hikma Pharmaceuticals USA Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Recall initiated
July 11, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01

by Hikma Pharmaceuticals USA Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Recall initiated
July 11, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.

by Glenmark Pharmaceuticals Inc., USA

Reason
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.

by Glenmark Pharmaceuticals Inc., USA

Reason
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass I

SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.

by Ultra Supplement LLC

Reason
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Recall initiated
July 21, 2022
Reported by FDA
August 10, 2022
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.

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Drug Recall Terminated Historical recordClass I

SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285

by Distributor RFR, LLC.

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Recall initiated
July 22, 2022
Reported by FDA
August 10, 2022
Distribution
Retail stores in the state of FL, Nationwide in the USA, France and Canada via website sales, and Bolivarian Republic of Venezuela

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Drug Recall Ongoing Historical recordClass III

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.

by Glenmark Pharmaceuticals Inc., USA

Reason
Defective Container: Tube split from side seam
Recall initiated
July 11, 2022
Reported by FDA
August 10, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.

by Teva Pharmaceuticals USA Inc

Reason
Failed Dissolution Specifications: below specification limits for dissolution.
Recall initiated
July 21, 2022
Reported by FDA
August 10, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.

by Teva Pharmaceuticals USA Inc

Reason
Failed Dissolution Specifications: below specification limits for dissolution.
Recall initiated
July 21, 2022
Reported by FDA
August 10, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

by Tolmar, Inc.

Reason
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Recall initiated
July 11, 2022
Reported by FDA
August 10, 2022
Distribution
distributed to 1 consignee in KY.

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Drug Recall Terminated Historical recordClass I

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

by Pfizer Inc.

Reason
Presence of particulate matter: particulate identified as a beetle.
Recall initiated
July 13, 2022
Reported by FDA
August 3, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

by Eco Lips, Inc

Reason
Failed Dissolution Specifications
Recall initiated
June 29, 2022
Reported by FDA
August 3, 2022
Distribution
CA

View recall →

Drug Recall Terminated Historical recordClass III

Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

by Eco Lips, Inc

Reason
Failed Dissolution Specifications
Recall initiated
June 29, 2022
Reported by FDA
August 3, 2022
Distribution
CA

View recall →

Drug Recall Terminated Historical recordClass II

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
July 18, 2022
Reported by FDA
August 3, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Failed dissolution specifications.
Recall initiated
July 18, 2022
Reported by FDA
August 3, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass I

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV

by MYLAN PHARMACEUTICALS INC

Reason
Labeling: Missing label: Label missing from some prefilled pens.
Recall initiated
July 5, 2022
Reported by FDA
August 3, 2022
Distribution
Product was distributed nationwide within the United States

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.