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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 6,081–6,100 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83

by Pfizer Inc.

Reason
Presence of Particulate Matter: particulate matter identified after reconstitution.
Recall initiated
May 29, 2020
Reported by FDA
June 17, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07

by QuVa Pharma, Inc.

Reason
Subpotent drug - Product did not contain drug.
Recall initiated
May 28, 2020
Reported by FDA
June 17, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall initiated
April 20, 2020
Reported by FDA
June 17, 2020
Distribution
USA Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall initiated
April 20, 2020
Reported by FDA
June 17, 2020
Distribution
USA Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11

by American Health Packaging

Reason
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Recall initiated
May 19, 2020
Reported by FDA
June 17, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01

by UNICHEM PHARMACEUTICALS USA INC

Reason
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Recall initiated
May 26, 2020
Reported by FDA
June 17, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.

by Lupin Pharmaceuticals Inc.

Reason
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Recall initiated
May 28, 2020
Reported by FDA
June 17, 2020
Distribution
Nationwide within the US.

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Drug Recall Terminated Historical recordClass II

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05

by Torrent Pharma Inc.

Reason
Failed Dissolution Specifications
Recall initiated
May 11, 2020
Reported by FDA
June 10, 2020
Distribution
USA Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01.

by Acella Pharmaceuticals, LLC

Reason
Superpotent Drug.
Recall initiated
May 22, 2020
Reported by FDA
June 10, 2020
Distribution
Distributed Nationwide in the US and Puerto Rico

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Drug Recall Terminated Historical recordClass I

NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01.

by Acella Pharmaceuticals, LLC

Reason
Superpotent Drug.
Recall initiated
May 22, 2020
Reported by FDA
June 10, 2020
Distribution
Distributed Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.

by Acella Pharmaceuticals, LLC

Reason
Superpotent Drug.
Recall initiated
May 22, 2020
Reported by FDA
June 10, 2020
Distribution
Distributed Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.

by AVKARE Inc.

Reason
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Recall initiated
May 28, 2020
Reported by FDA
June 10, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.

by The Harvard Drug Group

Reason
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Recall initiated
May 22, 2020
Reported by FDA
June 10, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02

by Teva Pharmaceuticals USA

Reason
Some bottles may contain mixed strengths of the product.
Recall initiated
May 22, 2020
Reported by FDA
June 10, 2020
Distribution
Nationwide within the United State and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02

by Teva Pharmaceuticals USA

Reason
Some bottles may contain mixed strengths of the product.
Recall initiated
May 22, 2020
Reported by FDA
June 10, 2020
Distribution
Nationwide within the United State and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02

by Teva Pharmaceuticals USA

Reason
Some bottles may contain mixed strengths of the product.
Recall initiated
May 22, 2020
Reported by FDA
June 10, 2020
Distribution
Nationwide within the United State and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02

by TRIOVA PHARMACEUTICALS LLC

Reason
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Recall initiated
May 15, 2020
Reported by FDA
June 10, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass III

Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Recall initiated
May 26, 2020
Reported by FDA
June 3, 2020
Distribution
TN

View recall →

Drug Recall Ongoing Historical recordClass II

Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.

by Wuhan Bingbing Pharmaceutical Co., Ltd.

Reason
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Recall initiated
May 19, 2020
Reported by FDA
June 3, 2020
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.

by Wuhan Bingbing Pharmaceutical Co., Ltd.

Reason
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Recall initiated
May 19, 2020
Reported by FDA
June 3, 2020
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.