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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

Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

by Pharmcore Inc.

Reason: Lack of assurance of sterility.
Recall initiated: August 2, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0

by RemedyRePack Inc.

Reason: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Recall initiated: August 20, 2018
Reported by FDA: September 5, 2018
Distribution: South Carolina

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Drug Recall Ongoing Historical recordClass II

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90

by Torrent Pharma Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 17, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 14, 2018
Reported by FDA: September 5, 2018
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 14, 2018
Reported by FDA: September 5, 2018
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 14, 2018
Reported by FDA: September 5, 2018
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: August 14, 2018
Reported by FDA: September 5, 2018
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass III

Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.

by Mayne Pharma Inc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Recall initiated: August 21, 2018
Reported by FDA: September 5, 2018
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18

by Baxter Healthcare Corporation

Reason: CGMP Deviations
Recall initiated: August 21, 2018
Reported by FDA: September 5, 2018
Distribution: TX and MS only

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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.