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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 961–980 of 1,000 recalls

Class IIITerminated

Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class IIITerminated

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.

Lupin Pharmaceuticals Inc.

CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

March 11, 2016 · Drug

View details →

Class IIITerminated

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class IIITerminated

col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.

Allegiant Health

Superpotent Drug: High out of specification results for assay at the 6 month time point interval.

February 29, 2016 · DrugView details →

Class IIITerminated

Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.

Torrent Pharmaceuticals Limited

Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.

February 25, 2016 · DrugView details →

Class IIITerminated

Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09

Lupin Limited

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

February 19, 2016 · DrugView details →

Class IIITerminated

Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03

Lupin Limited

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

February 19, 2016 · DrugView details →

Class IIITerminated

Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.

Apace KY LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.

February 12, 2016 · DrugView details →

Class IIITerminated

Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102

Ecolab Inc

Subpotent drug

February 12, 2016 · DrugView details →

Class IIITerminated

sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654

J. Strickland and Co

Subpotent Drug: failed at the 3 and 6 month stability time points.

February 11, 2016 · DrugView details →

Class IIITerminated

Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18

Pfizer Inc

Labeling: Label Mix-Up

February 10, 2016 · DrugView details →

Class IIITerminated

Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.

Medical Park Homecare, Inc

CGMP Deviations: Cylinders filled using out of date gauges.

February 5, 2016 · DrugView details →

Class IIITerminated

Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109

Isomeric Pharmacy Solution, LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.

February 2, 2016 · DrugView details →

Class IIITerminated

Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.

January 28, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)

Amerisource Health Services

Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

January 26, 2016 · DrugView details →

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