Category

Oral Drugs Recalls

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

5,039 recalls
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewat...
Oral Drugs·9,056 affected·May 30, 2023
RecallFDA
Aurolife Pharma, Llc
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13...
Oral Drugs·0 affected·May 18, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, I...
Oral Drugs·5,344 affected·May 9, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Oral Drugs·12,336 affected·May 3, 2023
High RiskFDA
Glenmark Therapeutics, Inc.
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made...
Oral Drugs·19,968 affected·May 1, 2023
High RiskFDA
Remedyrepack Inc.
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn...
Oral Drugs·29 affected·May 1, 2023
RecallFDA
Teva Pharmaceuticals Usa Inc
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharm...
Oral Drugs·1,908 affected·Apr 27, 2023
RecallFDA
Teva Pharmaceuticals Usa Inc
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharm...
Oral Drugs·1,272 affected·Apr 27, 2023
RecallFDA
Teva Pharmaceuticals Usa Inc
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharm...
Oral Drugs·397 affected·Apr 27, 2023
RecallFDA
Teva Pharmaceuticals Usa Inc
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharm...
Oral Drugs·3,032 affected·Apr 27, 2023
RecallFDA
Teva Pharmaceuticals Usa Inc
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharm...
Oral Drugs·438 affected·Apr 27, 2023
High RiskFDA
Akorn, Inc.
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 600...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: A...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Compan...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. AL...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Ami...
Oral Drugs·0 affected·Apr 26, 2023
CriticalFDA
Gadget Island, Inc
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Oral Drugs·140 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: ...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurne...
Oral Drugs·0 affected·Apr 26, 2023
CriticalFDA
Gadget Island, Inc
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 ...
Oral Drugs·628 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn O...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 6...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
CriticalFDA
Gadget Island, Inc
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Oral Drugs·18 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurn...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031....
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company-...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx On...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ...
Oral Drugs·0 affected·Apr 26, 2023
RecallFDA
The Harvard Drug Group
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo...
Oral Drugs·3,984 affected·Apr 24, 2023
High RiskFDA
Family Dollar Stores, Llc.
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Oral Drugs·0 affected·Mar 31, 2023
High RiskFDA
Family Dollar Stores, Llc.
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Oral Drugs·0 affected·Mar 31, 2023
High RiskFDA
Family Dollar Stores, Llc.
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 co...
Oral Drugs·0 affected·Mar 31, 2023
High RiskFDA
Family Dollar Stores, Llc.
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b)...
Oral Drugs·0 affected·Mar 31, 2023
RecallFDA
Teva Pharmaceuticals Usa Inc
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA...
Oral Drugs·3,772 affected·Mar 27, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
Oral Drugs·4 affected·Mar 23, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Oral Drugs·15 affected·Mar 23, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-76...
Oral Drugs·158 affected·Mar 23, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Oral Drugs·57 affected·Mar 23, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Oral Drugs·264 affected·Mar 23, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
Oral Drugs·32 affected·Mar 23, 2023