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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 17,581–17,600 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.

by Ranbaxy Inc.

Reason
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Recall initiated
November 9, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide and PR

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-828-90

by Ranbaxy Inc.

Reason
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Recall initiated
November 9, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide and PR

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90

by Ranbaxy Inc.

Reason
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Recall initiated
November 9, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide and PR

View recall →

Drug Recall Terminated Historical recordClass II

Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12

by Procter & Gamble Co

Reason
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Recall initiated
November 8, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06

by GlaxoSmithKline, LLC.

Reason
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Recall initiated
October 8, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

by Boehringer Ingelheim Roxane Inc

Reason
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Recall initiated
November 5, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

by Mylan LLC.

Reason
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Recall initiated
June 29, 2012
Reported by FDA
December 5, 2012
Distribution
Natiowide

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Drug Recall Terminated Historical recordClass III

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.

by GlaxoSmithKline, LLC.

Reason
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Recall initiated
October 24, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.

by GlaxoSmithKline, LLC.

Reason
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Recall initiated
October 24, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass I

Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)

by Samantha Lynn, Inc

Reason
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Recall initiated
August 27, 2012
Reported by FDA
December 5, 2012
Distribution
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan

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Drug Recall Terminated Historical recordClass II

Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA

by American Enterprises LLC dba Sterling Gelatin

Reason
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Recall initiated
September 21, 2012
Reported by FDA
November 28, 2012
Distribution
NJ

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Drug Recall Terminated Historical recordClass II

Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.

by Church & Dwight Inc

Reason
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Recall initiated
September 6, 2012
Reported by FDA
November 28, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90

by Ranbaxy Inc.

Reason
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Recall initiated
August 21, 2012
Reported by FDA
November 28, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Recall initiated
September 27, 2012
Reported by FDA
November 28, 2012
Distribution
Nationwide. No foreign consignees.

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Drug Recall Terminated Historical recordClass I

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.

by Watson Laboratories Inc

Reason
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Recall initiated
September 21, 2012
Reported by FDA
November 28, 2012
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass I

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Recall initiated
September 10, 2012
Reported by FDA
November 28, 2012
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass III

Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9.

by ITW Dymon

Reason
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Recall initiated
September 28, 2012
Reported by FDA
November 21, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com

by Ameridose LLC

Reason
GMP deficiencies
Recall initiated
October 31, 2012
Reported by FDA
November 21, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com

by Ameridose LLC

Reason
Lack of assurance of sterility
Recall initiated
October 31, 2012
Reported by FDA
November 21, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

by New England Compounding Center

Reason
GMP Deviations
Recall initiated
October 6, 2012
Reported by FDA
November 21, 2012
Distribution
Nationwide Japan

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.