Category

Oral Drugs Recalls

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

5,039 recalls
High RiskFDA
Amerisource Health Services Llc
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-...
Oral Drugs·26,992 affected·Jul 29, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., M...
Oral Drugs·1,856 affected·Jul 25, 2025
High RiskFDA
Alembic Pharmaceuticals Limited
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Guj...
Oral Drugs·9,492 affected·Jul 25, 2025
High RiskFDA
Ascend Laboratories, Llc
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Dist...
Oral Drugs·8,568 affected·Jul 21, 2025
High RiskFDA
Merck & Co. Inc
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Shar...
Oral Drugs·51,320 affected·Jul 21, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Bar...
Oral Drugs·1,829 affected·Jul 15, 2025
High RiskFDA
Nostrum Laboratories, Inc.
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only...
Oral Drugs·60,608 affected·Jul 11, 2025
High RiskFDA
Ascend Laboratories, Llc
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribut...
Oral Drugs·0 affected·Jul 9, 2025
High RiskFDA
Strides Pharma, Inc.
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Stri...
Oral Drugs·6,672 affected·Jul 9, 2025
High RiskFDA
Ascend Laboratories, Llc
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribute...
Oral Drugs·0 affected·Jul 9, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Nap...
Oral Drugs·7,668 affected·Jul 2, 2025
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally...
Oral Drugs·1,476 affected·Jun 30, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc...
Oral Drugs·12,242 affected·Jun 30, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 6818...
Oral Drugs·2,724 affected·Jun 27, 2025
RecallFDA
Avkare
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Oral Drugs·1,560 affected·Jun 26, 2025
RecallFDA
Avkare
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Oral Drugs·8,573 affected·Jun 26, 2025
High RiskFDA
Granules Pharmaceuticals Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70...
Oral Drugs·27,648 affected·Jun 24, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, ...
Oral Drugs·58,968 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC ...
Oral Drugs·4,921 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27...
Oral Drugs·82,159 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 276...
Oral Drugs·54,227 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC...
Oral Drugs·2,344 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC...
Oral Drugs·4,896 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC ...
Oral Drugs·2,352 affected·Jun 20, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2...
Oral Drugs·9,739 affected·Jun 20, 2025
High RiskFDA
The Harvard Drug Group Llc
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS...
Oral Drugs·23,232 affected·Jun 19, 2025
High RiskFDA
The Harvard Drug Group Llc
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, ...
Oral Drugs·3,527 affected·Jun 19, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901,...
Oral Drugs·5,448 affected·Jun 16, 2025
RecallFDA
Orient Pharma Co., Ltd. Yunlin Plant
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 6...
Oral Drugs·20,618 affected·Jun 11, 2025
RecallFDA
Macleods Pharmaceuticals Ltd
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharma...
Oral Drugs·9,888 affected·Jun 11, 2025
RecallFDA
Orient Pharma Co., Ltd. Yunlin Plant
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 6...
Oral Drugs·57,504 affected·Jun 11, 2025
CriticalFDA
Amneal Pharmaceuticals, Llc
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per B...
Oral Drugs·6,396 affected·Jun 2, 2025
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distribut...
Oral Drugs·11,616 affected·May 30, 2025
RecallFDA
Macleods Pharmaceuticals Ltd
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 085...
Oral Drugs·1,344 affected·May 29, 2025
High RiskFDA
Apotex Corp.
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured fo...
Oral Drugs·20,648 affected·May 28, 2025
High RiskFDA
Torrent Pharma Inc.
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manu...
Oral Drugs·972 affected·May 27, 2025
High RiskFDA
Torrent Pharma Inc.
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactur...
Oral Drugs·3,672 affected·May 27, 2025
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufact...
Oral Drugs·36,612 affected·May 23, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs·10,620 affected·May 23, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs·48,936 affected·May 23, 2025
High RiskFDA
Aurobindo Pharma Usa Inc
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72...
Oral Drugs·4,608 affected·May 22, 2025
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase...
Oral Drugs·6,759 affected·May 19, 2025
High RiskFDA
Amerisource Health Services Llc
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Heal...
Oral Drugs·21 affected·May 15, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim...
Oral Drugs·8,520 affected·May 15, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·22,152 affected·May 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·30,674 affected·May 13, 2025
High RiskFDA
Avkare
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Oral Drugs·3,817 affected·May 13, 2025
High RiskFDA
Avkare
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, N...
Oral Drugs·962 affected·May 9, 2025