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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 14,881–14,900 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated
August 27, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated
August 27, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated
August 27, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated
August 27, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated
August 27, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated
August 27, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated
August 27, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert
Recall initiated
June 5, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert
Recall initiated
June 5, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert
Recall initiated
June 5, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Recall initiated
October 8, 2014
Reported by FDA
November 5, 2014
Distribution
U.S. Nationwide including Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Recall initiated
October 21, 2014
Reported by FDA
November 5, 2014
Distribution
IL, OH, LA

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Drug Recall Terminated Historical recordClass II

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.

by Hi-Tech Pharmacal Co., Inc.

Reason
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Recall initiated
April 1, 2014
Reported by FDA
November 5, 2014
Distribution
nationwide

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Drug Recall Terminated Historical recordClass II

CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1

by Wisconsin Pharmacal Company

Reason
Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.
Recall initiated
October 3, 2014
Reported by FDA
November 5, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540

by Micro Labs Usa, Inc S

Reason
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Recall initiated
October 9, 2014
Reported by FDA
November 5, 2014
Distribution
CT, FL, MD, MS, NY

View recall →

Drug Recall Terminated Historical recordClass II

Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404.

by Gilead Sciences, Inc.

Reason
Defective Container; leaking around the cap
Recall initiated
October 1, 2014
Reported by FDA
November 5, 2014
Distribution
United States, Puerto Rico, Fiji.

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.

by Hospira Inc.

Reason
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Recall initiated
October 1, 2014
Reported by FDA
October 29, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11

by American Health Packaging

Reason
Subpotent; 6 month stability time point
Recall initiated
October 10, 2014
Reported by FDA
October 29, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India

by Aidarex Pharmaceuticals LLC

Reason
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Recall initiated
May 22, 2014
Reported by FDA
October 29, 2014
Distribution
Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS

View recall →

Drug Recall Terminated Historical recordClass II

ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528

by Zee Medical Products Inc

Reason
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Recall initiated
October 7, 2014
Reported by FDA
October 29, 2014
Distribution
Nationwide in US

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.