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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 III

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.

by Mylan Pharmaceuticals Inc.

Reason: Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Recall initiated: August 27, 2018
Reported by FDA: October 24, 2018
Distribution: Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA

by Humco Holding Group, Inc

Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recall initiated: August 28, 2018
Reported by FDA: October 24, 2018
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA

by Humco Holding Group, Inc

Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recall initiated: August 28, 2018
Reported by FDA: October 24, 2018
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501

by Humco Holding Group, Inc

Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recall initiated: August 28, 2018
Reported by FDA: October 24, 2018
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.

by GLAXOSMITHKLINE NEBRASKA

Reason: CGMP deviations
Recall initiated: September 26, 2018
Reported by FDA: October 17, 2018
Distribution: Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30

by Takeda Development Center Americas, Inc.

Reason: Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Recall initiated: September 10, 2018
Reported by FDA: October 17, 2018
Distribution: AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)

by Xiromed LLC

Reason: Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Recall initiated: September 18, 2018
Reported by FDA: October 17, 2018
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.

by Pfizer Inc.

Reason: Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Recall initiated: October 3, 2018
Reported by FDA: October 17, 2018
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0

by Syntec Pharma Corp

Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recall initiated: August 22, 2018
Reported by FDA: October 17, 2018
Distribution: Al & TX only

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Drug Recall Terminated Historical recordClass II

THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0

by Syntec Pharma Corp

Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recall initiated: August 22, 2018
Reported by FDA: October 17, 2018
Distribution: Al & TX only

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Drug Recall Terminated Historical recordClass III

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15

by InvaGen Pharmaceuticals, Inc.

Reason: Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Recall initiated: October 3, 2018
Reported by FDA: October 17, 2018
Distribution: Nationwide with the United States

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Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.

by Jubilant Cadista Pharmaceuticals, Inc.

Reason: Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Recall initiated: October 2, 2018
Reported by FDA: October 17, 2018
Distribution: Product was distributed Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2

by Pfizer Inc.

Reason: CGMP Deviations; rejected product was used to manufacture final bulk lot
Recall initiated: September 20, 2018
Reported by FDA: October 17, 2018
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298, NDC 7807-0170-11

by Alkano Chemicals, Inc

Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recall initiated: August 30, 2018
Reported by FDA: October 17, 2018
Distribution: Distributed to two compounding firms in Minnesota.

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Drug Recall Terminated Historical recordClass III

treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02

by Otsuka Pharmaceutical Development & Commercialization, Inc.

Reason: Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Recall initiated: September 17, 2018
Reported by FDA: October 10, 2018
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass III

treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01

by Otsuka Pharmaceutical Development & Commercialization, Inc.

Reason: Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Recall initiated: September 17, 2018
Reported by FDA: October 10, 2018
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass I

robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.

by Endo Pharmaceuticals, Inc.

Reason: Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Recall initiated: September 17, 2018
Reported by FDA: October 10, 2018
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India

by Dr. Reddy's Laboratories, Inc.

Reason: Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Recall initiated: September 21, 2018
Reported by FDA: October 10, 2018
Distribution: U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11

by Sichuan Friendly Pharmaceutical Co.,Ltd.

Reason: CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recall initiated: August 21, 2018
Reported by FDA: October 10, 2018
Distribution: Distributed nationwide and China

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Drug Recall Terminated Historical recordClass II

Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01

by Pfizer Inc.

Reason: Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Recall initiated: September 19, 2018
Reported by FDA: October 10, 2018
Distribution: U.S.A. nationwide. The following countries received product from Lot S91616: Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe and Iraq as part of the Compassionate Use Program.

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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.