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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 10621–10640 of 17,793 recalls

Class IIITerminated

Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →
Class IITerminated

Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class IIITerminated

Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →
Class IIITerminated

Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →
Class IIITerminated

Indian God Lotion Spray Bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class IIITerminated

Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →
Class IIITerminated

Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →
Class ITerminated

GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class ITerminated

LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class IITerminated

Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class IIITerminated

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →
Class IITerminated

Tiger King tablets, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class ITerminated

Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class ITerminated

YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class IIITerminated

Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →
Class ITerminated

DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class IIITerminated

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10).

Pfizer Inc

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

March 7, 2017 · DrugView details →
Class ITerminated

Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
Class IIITerminated

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30).

Pfizer Inc

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

March 7, 2017 · DrugView details →
Class ITerminated

ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →
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