Category

Oral Drugs Recalls

5,039 oral drugs recalls on record from CPSC, FDA, and USDA.

5,039 recalls
High RiskFDA
Safecor Health, Llc
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, ...
Oral Drugs·10,992 affected·Feb 17, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ ...
Oral Drugs·9,840 affected·Feb 6, 2025
High RiskFDA
Avkare
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals o...
Oral Drugs·1,266 affected·Feb 4, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distribu...
Oral Drugs·6,997 affected·Jan 30, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·87,600 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·80,160 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·119,040 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: ...
Oral Drugs·58,368 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·70,032 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·133,824 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·56,208 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·58,416 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·175,920 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of Indi...
Oral Drugs·39,168 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·53,952 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·190,320 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·120,000 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·233,040 affected·Jan 29, 2025
High RiskFDA
Remedyrepack Inc.
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged...
Oral Drugs·247 affected·Jan 24, 2025
High RiskFDA
Sky Packaging
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distrib...
Oral Drugs·0 affected·Jan 24, 2025
High RiskFDA
Sky Packaging
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, Ind...
Oral Drugs·0 affected·Jan 24, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark P...
Oral Drugs·0 affected·Jan 22, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pha...
Oral Drugs·0 affected·Jan 22, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this pac...
Oral Drugs·82,281 affected·Jan 21, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa...
Oral Drugs·94,349 affected·Jan 21, 2025
High RiskFDA
Avkare
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Oral Drugs·341 affected·Jan 21, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa...
Oral Drugs·27,525 affected·Jan 21, 2025
RecallFDA
Appco Pharma Llc
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Oral Drugs·1,380 affected·Jan 16, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses ...
Oral Drugs·6,408 affected·Jan 13, 2025
RecallFDA
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc....
Oral Drugs·4,080 affected·Jan 7, 2025
High RiskFDA
Amerisource Health Services Llc
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by...
Oral Drugs·4,640 affected·Jan 7, 2025
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Dist...
Oral Drugs·42,527 affected·Dec 30, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Ph...
Oral Drugs·244,460 affected·Dec 30, 2024
High RiskFDA
Granules Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyde...
Oral Drugs·6,804 affected·Dec 30, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ...
Oral Drugs·73,680 affected·Dec 30, 2024
CriticalFDA
Astellas Pharma Us Inc.
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northb...
Oral Drugs·14,340 affected·Dec 23, 2024
High RiskFDA
Viatris Inc
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 2650...
Oral Drugs·1,215 affected·Dec 23, 2024
High RiskFDA
Viatris Inc
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 265...
Oral Drugs·6,605 affected·Dec 23, 2024
CriticalFDA
Astellas Pharma Us Inc.
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma U...
Oral Drugs·3,500 affected·Dec 23, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Ma...
Oral Drugs·480 affected·Dec 20, 2024
RecallFDA
West-ward Columbus Inc
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Hei...
Oral Drugs·2,591 affected·Dec 19, 2024
High RiskFDA
Granules Pharmaceuticals Inc.
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Oral Drugs·96 affected·Dec 18, 2024
High RiskFDA
Amerisource Health Services Llc
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Co...
Oral Drugs·2,028 affected·Dec 17, 2024
CriticalFDA
Shoppers- Plaza
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of...
Oral Drugs·172 affected·Dec 16, 2024
High RiskFDA
Amerisource Health Services Llc
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by...
Oral Drugs·5,178 affected·Dec 13, 2024
RecallFDA
Akron Pharma, Inc.
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-...
Oral Drugs·14,825 affected·Dec 12, 2024
RecallFDA
Akron Pharma, Inc.
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suit...
Oral Drugs·456 affected·Dec 12, 2024
RecallFDA
Akron Pharma, Inc.
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suit...
Oral Drugs·324 affected·Dec 12, 2024