FDA Enforcement Records
Explore FDA enforcement records
Browse published US FDA drug-enforcement recall records. Filter by country, classification, status, or date.
Showing 2351–2375 of 4,679 active FDA enforcement records · Country: united states
- View firm →Class IIOngoingSafe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. · Jun 7, 2023 · United States
- View firm →Class IIOngoingPin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02 · Jun 7, 2023 · United States
- View firm →Class IIOngoingColic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240. · Jun 7, 2023 · United States
- View firm →Class IIOngoingSafe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. · Jun 7, 2023 · United States
- View firm →Class IIOngoingTirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64. · May 31, 2023 · United States
- View firm →Class IIITerminatedFentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28 · May 31, 2023 · United States
- View firm →Class IIITerminatedFentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28 · May 31, 2023 · United States
- View firm →Class IIITerminatedFentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28 · May 31, 2023 · United States
- View firm →Class IIITerminatedFentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28 · May 31, 2023 · United States
- View firm →Class IIITerminatedFentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28 · May 31, 2023 · United States
- View firm →Class IICompletedPain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35. · May 31, 2023 · United States
- View firm →Class IIOngoingNafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99 · May 31, 2023 · United States
- View firm →Class IIOngoingNafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10 · May 31, 2023 · United States
- View firm →Class IIOngoingNafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10 · May 31, 2023 · United States
- View firm →Class IITerminatedbuPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86 · May 31, 2023 · United States
- View firm →Class IITerminatedFOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238, · May 31, 2023 · United States
- View firm →Class IITerminatedGlimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories · May 31, 2023 · United States
- View firm →Class IITerminatedGlimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories · May 31, 2023 · United States
- View firm →Class IITerminatedGlimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories · May 31, 2023 · United States
- View firm →Class IIITerminatedMethylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01. · May 31, 2023 · United States
- View firm →Class IITerminatedHyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942. · May 31, 2023 · United States
- View firm →Class IITerminatedHyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941. · May 31, 2023 · United States
- View firm →Class IITerminatedLidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911. · May 31, 2023 · United States
- View firm →Class IITerminatedPotassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781. · May 31, 2023 · United States
- View firm →Class IITerminatedSodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771. · May 31, 2023 · United States
Only the latest five years of published US FDA drug-enforcement recall records are indexed. The displayed entity is an FDA-recorded recalling firm; country, city, and state are source attributes, not proof of manufacturer, parent company, ownership, legal entity, safety, compliance, or approval.