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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 881–900 of 1,000 recalls

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gaia Ethnobotanical White Horn, 1 oz, 250g, 1kg Gaia Ethnobotanical White MD, 1 oz, 250 g, 1 kg Gaia Ethnobotanical White Thai, 1oz, 250 g, 1 kg Gaia Ethnobotanical Yellow Thai, 1oz, 250 g, 1kg Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

June 20, 2018 · DrugView details →

Class ITerminated

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL

HOSPIRA INC, LAKE FOREST

Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

June 4, 2018 · DrugView details →

Class ITerminated

Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290

Allergan, PLC.

Contraceptive Tablets Out of Sequence.

May 24, 2018 · DrugView details →

Class ITerminated

7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148

Shoreside Enterprises Inc.

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

May 17, 2018 · DrugView details →

Class ITerminated

POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857

Shoreside Enterprises Inc.

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

May 17, 2018 · DrugView details →

Class ITerminated

Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4

Apotex Inc.

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

May 8, 2018 · DrugView details →

Class ITerminated

Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4

Apotex Inc.

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

May 8, 2018 · DrugView details →

Class ITerminated

Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.

AuroMedics Pharma LLC

Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.

May 1, 2018 · DrugView details →

Class ITerminated

Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30

AuroMedics Pharma LLC

Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass

May 1, 2018 · DrugView details →

Class ITerminated

Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.

Epic Products, LLC

Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.

April 16, 2018 · DrugView details →

Class ITerminated

Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128

AMA Wholesale

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

April 12, 2018 · DrugView details →

Class ITerminated

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

Bayer HealthCare Pharmaceuticals, Inc.

Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.

March 15, 2018 · DrugView details →

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