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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 301–320 of 1,000 recalls

Class ITerminated

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.

Acella Pharmaceuticals, LLC

Superpotent Drug.

May 22, 2020 · DrugView details →

Class ITerminated

LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

ICU Medical Inc

Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

May 8, 2020 · DrugView details →

Class ITerminated

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.

Fresenius Kabi USA, LLC

Presence of Particulate Matter - found in reserve sample vials at the firm.

April 20, 2020 · DrugView details →

Class ITerminated

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

B. Braun Medical Inc

Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.

April 18, 2020 · DrugView details →

Class ITerminated

KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE.

Summitt Labs

Chemical Contamination; product contains elevated levels of lead

April 15, 2020 · DrugView details →

Class ITerminated

Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.

MasterPharm LLC

Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.

April 14, 2020 · DrugView details →

Class ITerminated

Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

Avet Pharmaceuticals, Inc.

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

March 23, 2020 · DrugView details →

Class ITerminated

Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

Avet Pharmaceuticals, Inc.

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

March 23, 2020 · DrugView details →

Class ITerminated

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501

Y-O Management LLC, dba Natural Remedy Store

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

March 16, 2020 · DrugView details →

Class ITerminated

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.

Dr. Reddy's Laboratories, Inc.

Defective Container: Recall is due to breaking and shattering of ampules upon opening

March 16, 2020 · DrugView details →

Class ITerminated

Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1

Taro Pharmaceuticals U.S.A., Inc.

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

February 7, 2020 · DrugView details →

Class ITerminated

Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00

RemedyRepack Inc.

Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

December 27, 2019 · DrugView details →

Class ITerminated

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

Taro Pharmaceuticals U.S.A., Inc.

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

December 20, 2019 · DrugView details →

Class ITerminated

Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX

Motto International Corp

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

December 17, 2019 · DrugView details →

Class ITerminated

Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

Motto International Corp

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

December 17, 2019 · DrugView details →

Class ITerminated

Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX

Motto International Corp

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

December 17, 2019 · DrugView details →

Class ITerminated

Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

Motto International Corp

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

December 17, 2019 · DrugView details →

Class ITerminated

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

Hikma Pharmaceuticals USA Inc.

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

December 17, 2019 · DrugView details →

Class ITerminated

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80

Lannett Company, Inc.

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

December 6, 2019 · DrugView details →

Class ITerminated

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05

AuroMedics Pharma LLC

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

November 20, 2019 · DrugView details →

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