Category

Oral Drugs Recalls

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

5,039 recalls
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 4...
Oral Drugs·7,448 affected·Jan 29, 2026
High RiskFDA
Radnostix
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, ...
Oral Drugs·16 affected·Jan 26, 2026
High RiskFDA
Unichem Pharmaceuticals Usa Inc.
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS...
Oral Drugs·0 affected·Jan 21, 2026
RecallFDA
Unichem Pharmaceuticals Usa Inc.
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulev...
Oral Drugs·60,000 affected·Jan 21, 2026
High RiskFDA
Greenstone Llc
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, ...
Oral Drugs·3,456 affected·Jan 15, 2026
High RiskFDA
Amerisource Health Services Llc
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in ...
Oral Drugs·31,676 affected·Jan 14, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ ...
Oral Drugs·8,376 affected·Jan 12, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ ...
Oral Drugs·21,984 affected·Jan 12, 2026
High RiskFDA
Graviti Pharmaceuticals Private Limited
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactu...
Oral Drugs·4,212 affected·Jan 10, 2026
High RiskFDA
Alvogen, Inc
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Di...
Oral Drugs·0 affected·Dec 31, 2025
High RiskFDA
Avkare
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: ...
Oral Drugs·7,991 affected·Dec 31, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: G...
Oral Drugs·96,948 affected·Dec 30, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus...
Oral Drugs·22,896 affected·Dec 30, 2025
High RiskFDA
Gold Star Distribution Inc
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispen...
Oral Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packe...
Oral Drugs·0 affected·Dec 26, 2025
CriticalFDA
Handelnine Global Llc
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
Oral Drugs·4 affected·Dec 22, 2025
RecallFDA
Zydus Pharmaceuticals (usa) Inc
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zyd...
Oral Drugs·2,136 affected·Dec 19, 2025
High RiskFDA
Sato Pharmaceutical Co., Ltd
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmac...
Oral Drugs·3,640 affected·Dec 19, 2025
High RiskFDA
Specgx, Llc
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Oral Drugs·287,988 affected·Dec 16, 2025
High RiskFDA
Specgx, Llc
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01....
Oral Drugs·74,544 affected·Dec 16, 2025
RecallFDA
Alembic Pharmaceuticals Limited
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389...
Oral Drugs·0 affected·Dec 16, 2025
RecallFDA
Novadoz Pharmaceuticals Llc
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distr...
Oral Drugs·0 affected·Dec 15, 2025
CriticalFDA
Stuffbynainax
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Oral Drugs·4 affected·Dec 15, 2025
High RiskFDA
Merck Sharp & Dohme Llc
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07...
Oral Drugs·3 affected·Dec 12, 2025
High RiskFDA
Merck Sharp & Dohme Llc
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Shar...
Oral Drugs·845 affected·Dec 12, 2025
High RiskFDA
Golden State Medical Supply Inc.
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Oral Drugs·2,472 affected·Nov 26, 2025
RecallFDA
Winder Laboratories, Llc
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC...
Oral Drugs·3,528 affected·Nov 26, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotr...
Oral Drugs·7,389 affected·Nov 24, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotr...
Oral Drugs·3,397 affected·Nov 24, 2025
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-cou...
Oral Drugs·11,136 affected·Nov 21, 2025
RecallFDA
Glenmark Pharmaceuticals Inc., Usa
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India...
Oral Drugs·672 affected·Nov 18, 2025
High RiskFDA
Preferred Pharmaceuticals, Inc.
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals...
Oral Drugs·575 affected·Nov 17, 2025
High RiskFDA
Cipla Usa, Inc.
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Su...
Oral Drugs·12,576 affected·Nov 14, 2025
High RiskFDA
Cipla Usa, Inc.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Su...
Oral Drugs·63,504 affected·Nov 14, 2025
High RiskFDA
Cipla Usa, Inc.
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Su...
Oral Drugs·15,744 affected·Nov 14, 2025
RecallFDA
Dr. Reddy's Laboratories, Inc.
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-...
Oral Drugs·4,800 affected·Nov 11, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108...
Oral Drugs·52,128 affected·Nov 5, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Agebox
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 ...
Oral Drugs·665 affected·Oct 28, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, ...
Oral Drugs·0 affected·Oct 28, 2025
High RiskFDA
Cipla Usa, Inc.
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, I...
Oral Drugs·1,180 affected·Oct 24, 2025
High RiskFDA
Cipla Usa, Inc.
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, I...
Oral Drugs·0 affected·Oct 24, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. ...
Oral Drugs·36,624 affected·Oct 23, 2025