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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 9,541–9,560 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857

by Shoreside Enterprises Inc.

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Recall initiated
May 17, 2018
Reported by FDA
June 6, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102

by LUPIN SOMERSET

Reason
Labeling: Missing Label
Recall initiated
May 24, 2018
Reported by FDA
June 6, 2018
Distribution
OH

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Drug Recall Terminated Historical recordClass III

Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)

by Teva Pharmaceuticals USA

Reason
Failed Stability Specifications
Recall initiated
April 30, 2018
Reported by FDA
May 30, 2018
Distribution
United States

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Drug Recall Terminated Historical recordClass II

My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.

by Lupin Pharmaceuticals Inc.

Reason
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Recall initiated
May 17, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.

by Lupin Pharmaceuticals Inc.

Reason
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Recall initiated
May 17, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.

by Ideaz Llc

Reason
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Recall initiated
May 16, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Terminated Historical recordClass III

Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

by Milbar Laboratories, Inc.

Reason
Subpotent
Recall initiated
May 4, 2018
Reported by FDA
May 30, 2018
Distribution
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.

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Drug Recall Terminated Historical recordClass III

T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

by Milbar Laboratories, Inc.

Reason
Subpotent
Recall initiated
May 4, 2018
Reported by FDA
May 30, 2018
Distribution
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.

View recall →

Drug Recall Terminated Historical recordClass II

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22

by Mylan Pharmaceuticals Inc.

Reason
CGMP Deviations
Recall initiated
April 30, 2018
Reported by FDA
May 30, 2018
Distribution
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22

by Mylan Pharmaceuticals Inc.

Reason
CGMP Deviations
Recall initiated
April 30, 2018
Reported by FDA
May 30, 2018
Distribution
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22

by Mylan Pharmaceuticals Inc.

Reason
CGMP Deviations
Recall initiated
April 30, 2018
Reported by FDA
May 30, 2018
Distribution
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

by Fresenius Medical Care Renal Therapies Group, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 13, 2017
Reported by FDA
May 30, 2018
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.

by Exela Pharma Sciences LLC

Reason
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Recall initiated
April 20, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01

by Mylan Pharmaceuticals Inc.

Reason
CGMP Deviations
Recall initiated
April 24, 2018
Reported by FDA
May 30, 2018
Distribution
Product was distributed throughout the United States, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

by Mylan Pharmaceuticals Inc.

Reason
CGMP Deviations
Recall initiated
April 24, 2018
Reported by FDA
May 30, 2018
Distribution
Product was distributed throughout the United States, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.

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

Reason
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Recall initiated
May 1, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20

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

Reason
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Recall initiated
May 1, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass I

Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128

by AMA Wholesale

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Recall initiated
April 12, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.

by Ideaz Llc

Reason
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Recall initiated
May 16, 2018
Reported by FDA
May 30, 2018
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Terminated Historical recordClass I

Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Recall initiated
May 1, 2018
Reported by FDA
May 23, 2018
Distribution
Nationwide in the USA

View recall →

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.