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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 14,921–14,940 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass I

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05

by Hospira Inc.

Reason
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Recall initiated
July 29, 2014
Reported by FDA
October 22, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Recall initiated
May 21, 2014
Reported by FDA
October 22, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Recall initiated
May 21, 2014
Reported by FDA
October 22, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808

by Unit Dose Solutions Inc

Reason
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Recall initiated
June 2, 2014
Reported by FDA
October 22, 2014
Distribution
PA

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Drug Recall Terminated Historical recordClass II

HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.

by Avella of Deer Valley, Inc.

Reason
Crystallization: Formation of crystals observed in product.
Recall initiated
October 1, 2014
Reported by FDA
October 22, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.

by Zydus Pharmaceuticals USA Inc

Reason
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Recall initiated
September 15, 2014
Reported by FDA
October 22, 2014
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass III

E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01

by Bracco Diagnostic Inc

Reason
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Recall initiated
September 18, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1

by Gilead Sciences, Inc.

Reason
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Recall initiated
September 30, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

All sterile products within expiry

by Unique Pharmaceutical, Ltd

Reason
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Recall initiated
July 18, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

by Unique Pharmaceutical, Ltd

Reason
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Recall initiated
July 18, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.

by VistaPharm, Inc.

Reason
Defective Container: Product leaks when inverted.
Recall initiated
August 13, 2014
Reported by FDA
October 15, 2014
Distribution
U.S. Nationwide, including Puerto Rico

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Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.

by Mylan Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Recall initiated
July 3, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01

by Astellas Pharma US Inc

Reason
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Recall initiated
September 15, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01

by Zydus Pharmaceuticals USA Inc

Reason
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Recall initiated
August 5, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99

by Janssen Ortho L.L.C.

Reason
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Recall initiated
September 17, 2014
Reported by FDA
October 15, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.

by McKesson

Reason
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Recall initiated
September 12, 2014
Reported by FDA
October 15, 2014
Distribution
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.

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Drug Recall Terminated Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.

by Actavis Laboratories, FL, Inc.

Reason
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Recall initiated
April 24, 2014
Reported by FDA
October 8, 2014
Distribution
Nationwide and Puerto Rico

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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: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

by Actavis Laboratories, FL, Inc.

Reason
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Recall initiated
April 24, 2014
Reported by FDA
October 8, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82

by Sagent Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility; leaking of premix bags
Recall initiated
March 4, 2014
Reported by FDA
October 8, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663

by Eugene Oregon, Inc.

Reason
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Recall initiated
May 5, 2014
Reported by FDA
October 8, 2014
Distribution
To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC

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.