FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 110 of 348
Low Jul 1, 2020
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus…
American Health Packaging
Low Jul 1, 2020
Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distribu…
Pfizer Inc.
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.…
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
BIOTA Biosciences LLC
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewa…
Amneal Pharmaceuticals of New York, LLC
Low Jul 1, 2020
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, I…
Rising Pharmaceuticals, Inc.
Moderate Jul 1, 2020
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor…
Aurobindo Pharma USA Inc.
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgew…
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC…
Crown Laboratories
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC …
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD M…
Lupin Pharmaceuticals Inc.
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178…
Amneal Pharmaceuticals of New York, LLC
Low Jul 1, 2020
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Bro…
Rising Pharmaceuticals, Inc.
Moderate Jul 1, 2020
Sterile Curcumin 50mg/mL, 10 mL vial
BIOTA Biosciences LLC
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, N…
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
Sterile Curcumin, 4mg/mL, 10mL vial
BIOTA Biosciences LLC
Moderate Jul 1, 2020
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 3893…
Alembic Pharmaceuticals Limited
Moderate Jul 1, 2020
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
BIOTA Biosciences LLC
Low Jul 1, 2020
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08…
QuVa Pharma, Inc.
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedab…
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Wat…
Teva Pharmaceuticals USA
Moderate Jul 1, 2020
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
BIOTA Biosciences LLC
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahm…
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72…
PD-Rx Pharmaceuticals, Inc.
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewate…
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. …
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewa…
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. …
Amneal Pharmaceuticals of New York, LLC
Moderate Jul 1, 2020
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC …
Crown Laboratories
Moderate Jul 1, 2020
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UP…
A.P. Deauville, LLC
Low Jun 24, 2020
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma…
Aurobindo Pharma USA Inc.
Moderate Jun 24, 2020
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
Glaxosmithkline Consumer Healthcare Holdings
Moderate Jun 24, 2020
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 7000…
SCA Pharmaceuticals
Moderate Jun 24, 2020
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets …
PD-Rx Pharmaceuticals, Inc.
Moderate Jun 24, 2020
EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, …
Eco Lips Inc
Moderate Jun 24, 2020
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291…
AVKARE Inc.
Moderate Jun 24, 2020
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Dist…
Hikma Pharmaceuticals USA Inc.
Moderate Jun 24, 2020
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-…
Glaxosmithkline Consumer Healthcare Holdings
Moderate Jun 24, 2020
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T…
Apotex Inc.
Low Jun 24, 2020
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma…
Aurobindo Pharma USA Inc.
Moderate Jun 24, 2020
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07…
Glaxosmithkline Consumer Healthcare Holdings
Moderate Jun 24, 2020
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Dis…
Hikma Pharmaceuticals USA Inc.
Moderate Jun 24, 2020
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
Glaxosmithkline Consumer Healthcare Holdings
Moderate Jun 24, 2020
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-6…
AVKARE Inc.
Critical Jun 17, 2020
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…
Fresenius Kabi USA, LLC
Low Jun 17, 2020
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04
Akorn, Inc.
Low Jun 17, 2020
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bard…
UNICHEM PHARMACEUTICALS USA INC
Moderate Jun 17, 2020
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…
QuVa Pharma, Inc.
Moderate Jun 17, 2020
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin …
Lupin Pharmaceuticals Inc.
Moderate Jun 17, 2020
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 Vi…
Fresenius Kabi USA, LLC