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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 4,141–4,160 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass I

Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Recall initiated
March 8, 2022
Reported by FDA
April 6, 2022
Distribution
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.

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Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications; during long term stability testing.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications; during long term stability testing.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.

by Aurolife Pharma, LLC

Reason
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Recall initiated
March 17, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy

by Drug Depot, Inc., dba APS Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
March 23, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Recall initiated
February 25, 2022
Reported by FDA
April 6, 2022
Distribution
Product was distributed to one retail consignee in NY.

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Drug Recall Terminated Historical recordClass III

Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Recall initiated
March 16, 2022
Reported by FDA
April 6, 2022
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047

by Fresenius Kabi USA, LLC

Reason
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Recall initiated
March 4, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01

by Tennessee Technical Coatings, Corp.

Reason
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Recall initiated
March 3, 2022
Reported by FDA
March 30, 2022
Distribution
Distributed in AL, TN

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Drug Recall Terminated Historical recordClass I

HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01

by Tennessee Technical Coatings, Corp.

Reason
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Recall initiated
March 3, 2022
Reported by FDA
March 30, 2022
Distribution
Distributed in AL, TN

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Drug Recall Terminated Historical recordClass II

Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Super Potent and Failed Reconstitution Time
Recall initiated
March 8, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Sub Potent
Recall initiated
March 8, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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Drug Recall Terminated Historical recordClass III

SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Sub Potent
Recall initiated
March 8, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA including Puerto Rico.

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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.