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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 6,641–6,660 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass III

SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

by Idelle Labs

Reason
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Recall initiated
November 20, 2019
Reported by FDA
January 15, 2020
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912

by Idelle Labs

Reason
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Recall initiated
November 20, 2019
Reported by FDA
January 15, 2020
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38

by Asclemed USA Inc. dba Enovachem Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Recall initiated
December 9, 2019
Reported by FDA
January 15, 2020
Distribution
Product was distributed to 6 physician's offices within the state of California.

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Drug Recall Terminated Historical recordClass II

Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37

by Asclemed USA Inc. dba Enovachem Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Recall initiated
December 9, 2019
Reported by FDA
January 15, 2020
Distribution
Product was distributed to 6 physician's offices within the state of California.

View recall →

Drug Recall Terminated Historical recordClass II

Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36

by Asclemed USA Inc. dba Enovachem Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Recall initiated
December 9, 2019
Reported by FDA
January 15, 2020
Distribution
Product was distributed to 6 physician's offices within the state of California.

View recall →

Drug Recall Terminated Historical recordClass II

Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.

by Appco Pharma LLC

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
January 7, 2020
Reported by FDA
January 15, 2020
Distribution
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.

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Drug Recall Terminated Historical recordClass II

Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.

by Appco Pharma LLC

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
January 7, 2020
Reported by FDA
January 15, 2020
Distribution
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.

View recall →

Drug Recall Terminated Historical recordClass II

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

by AAA Pharmaceutical, Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
December 26, 2019
Reported by FDA
January 15, 2020
Distribution
Product was distributed to one consignee who may have distributed the product further to their retail stores.

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Drug Recall Terminated Historical recordClass II

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

by AAA Pharmaceutical, Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
December 26, 2019
Reported by FDA
January 15, 2020
Distribution
Product was distributed to one consignee who may have distributed the product further to their retail stores.

View recall →

Drug Recall Ongoing Historical recordClass II

Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
December 17, 2019
Reported by FDA
January 15, 2020
Distribution
Natiowide

View recall →

Drug Recall Ongoing Historical recordClass II

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
December 17, 2019
Reported by FDA
January 15, 2020
Distribution
Natiowide

View recall →

Drug Recall Ongoing Historical recordClass II

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
December 17, 2019
Reported by FDA
January 15, 2020
Distribution
Natiowide

View recall →

Drug Recall Ongoing Historical recordClass II

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
December 17, 2019
Reported by FDA
January 15, 2020
Distribution
Natiowide

View recall →

Drug Recall Ongoing Historical recordClass II

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
December 17, 2019
Reported by FDA
January 15, 2020
Distribution
Natiowide

View recall →

Drug Recall Ongoing Historical recordClass II

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
December 17, 2019
Reported by FDA
January 15, 2020
Distribution
Natiowide

View recall →

Drug Recall Terminated Historical recordClass II

Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11

by Lupin Pharmaceuticals Inc.

Reason
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Recall initiated
December 26, 2019
Reported by FDA
January 15, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.

by Akorn, Inc.

Reason
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Recall initiated
November 15, 2019
Reported by FDA
January 8, 2020
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Recall initiated
December 13, 2019
Reported by FDA
January 8, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass III

PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.

by Island Kinetics, Inc. d.b.a. CoValence Laboratories

Reason
Superpotent Drug: Salicylic acid content is above the firm's specification.
Recall initiated
December 20, 2019
Reported by FDA
January 8, 2020
Distribution
AZ

View recall →

Drug Recall Terminated Historical recordClass I

Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.

by Natures Rx

Reason
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Recall initiated
November 13, 2019
Reported by FDA
January 8, 2020
Distribution
Nationwide in the U.S.

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.