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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 11,041–11,060 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1

by Isomeric Pharmacy Solution, LLC

Reason
CGMP Deviations
Recall initiated
March 8, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications
Recall initiated
February 7, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).

by Pfizer Inc.

Reason
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Recall initiated
November 22, 2016
Reported by FDA
March 22, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31

by Sandoz Inc

Reason
Failed Dissolution Specifications
Recall initiated
February 10, 2017
Reported by FDA
March 15, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05

by Actavis Inc

Reason
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Recall initiated
February 7, 2017
Reported by FDA
March 15, 2017
Distribution
Nationwide

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Drug Recall Completed Historical recordClass II

Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.

by Mckesson Packaging Services

Reason
Presence of Foreign Substance: foreign material found in the bulk inventory.
Recall initiated
February 23, 2017
Reported by FDA
March 15, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.

by Endo Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Recall initiated
February 22, 2017
Reported by FDA
March 15, 2017
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Recall initiated
February 17, 2017
Reported by FDA
March 15, 2017
Distribution
Nationwide in the United States and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040

by LEO PHARMA INC

Reason
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Recall initiated
January 19, 2017
Reported by FDA
March 15, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

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

Reason
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Recall initiated
January 27, 2017
Reported by FDA
March 15, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

by Mylan Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Recall initiated
January 19, 2017
Reported by FDA
March 15, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications - low dissolution results at S3 stage.
Recall initiated
February 15, 2017
Reported by FDA
March 8, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass III

Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications - low dissolution results at S3 stage.
Recall initiated
February 15, 2017
Reported by FDA
March 8, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications - low dissolution results at S3 stage.
Recall initiated
February 15, 2017
Reported by FDA
March 8, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications - low dissolution results at S3 stage.
Recall initiated
February 15, 2017
Reported by FDA
March 8, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.

by Pacific Medical Solutions

Reason
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Recall initiated
December 13, 2016
Reported by FDA
March 8, 2017
Distribution
Nationwide in the United States and Mexico

View recall →

Drug Recall Terminated Historical recordClass III

Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.

by L. Perrigo Company

Reason
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Recall initiated
February 13, 2017
Reported by FDA
March 8, 2017
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass III

Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.

by L. Perrigo Company

Reason
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Recall initiated
February 13, 2017
Reported by FDA
March 8, 2017
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass II

Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Recall initiated
January 5, 2017
Reported by FDA
March 8, 2017
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43

by G & W Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Recall initiated
February 7, 2017
Reported by FDA
March 8, 2017
Distribution
Within United States

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.