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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

Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason: Lack of Assurance of Sterility.
Recall initiated: June 26, 2019
Reported by FDA: July 17, 2019
Distribution: ID, WA only

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason: Lack of Assurance of Sterility.
Recall initiated: June 26, 2019
Reported by FDA: July 17, 2019
Distribution: ID, WA only

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252.

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason: Lack of Assurance of Sterility.
Recall initiated: June 26, 2019
Reported by FDA: July 17, 2019
Distribution: ID, WA only

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason: Lack of Assurance of Sterility.
Recall initiated: June 26, 2019
Reported by FDA: July 17, 2019
Distribution: ID, WA only

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Drug Recall Terminated Historical recordClass II

Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories

by American Health Packaging

Reason: GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Recall initiated: May 9, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.

by MAJOR PHARMACEUTICALS

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Recall initiated: January 10, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90

by Golden State Medical Supply Inc.

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 14, 2019
Reported by FDA: July 17, 2019
Distribution: US Nationwide One (1) US government account. No foreign accounts.

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Drug Recall Terminated Historical recordClass II

Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10

by Golden State Medical Supply Inc.

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 14, 2019
Reported by FDA: July 17, 2019
Distribution: US Nationwide One (1) US government account. No foreign accounts.

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Drug Recall Terminated Historical recordClass II

Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90

by Golden State Medical Supply Inc.

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 14, 2019
Reported by FDA: July 17, 2019
Distribution: US Nationwide One (1) US government account. No foreign accounts.

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Drug Recall Terminated Historical recordClass II

Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30

by Golden State Medical Supply Inc.

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 14, 2019
Reported by FDA: July 17, 2019
Distribution: US Nationwide One (1) US government account. No foreign accounts.

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Drug Recall Terminated Historical recordClass II

Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10

by Macleods Pharma Usa Inc

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 20, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10

by Macleods Pharma Usa Inc

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 20, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10

by Macleods Pharma Usa Inc

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 20, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44

by Macleods Pharma Usa Inc

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 20, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10

by Macleods Pharma Usa Inc

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 20, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

by Teva Pharmaceuticals USA

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 6, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide by 4 major distributors.

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Drug Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00

by Teva Pharmaceuticals USA

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recall initiated: June 6, 2019
Reported by FDA: July 17, 2019
Distribution: Nationwide by 4 major distributors.

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Drug Recall Terminated Historical recordClass I

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78

by PharMEDium Services, LLC

Reason: Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Recall initiated: June 7, 2019
Reported by FDA: July 10, 2019
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44

by InvaGen Pharmaceuticals, Inc.

Reason: Defective Container; actuator may improperly function and affect dose delivery.
Recall initiated: June 12, 2019
Reported by FDA: July 10, 2019
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01

by Amneal Pharmaceuticals, Inc.

Reason: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Recall initiated: September 25, 2017
Reported by FDA: July 10, 2019
Distribution: Nationwide within the United States

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Data last updated: September 18, 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.