Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0793-2023 | 04-26-2023 | Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0864-2023 | 04-26-2023 | Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0801-2023 | 04-26-2023 | DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0804-2023 | 04-26-2023 | Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0782-2023 | 04-26-2023 | Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0805-2023 | 04-26-2023 | Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0822-2023 | 04-26-2023 | Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0784-2023 | 04-26-2023 | Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0786-2023 | 04-26-2023 | Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0792-2023 | 04-26-2023 | Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0810-2023 | 04-26-2023 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0811-2023 | 04-26-2023 | Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0837-2023 | 04-26-2023 | Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0798-2023 | 04-26-2023 | DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0816-2023 | 04-26-2023 | Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0845-2023 | 04-26-2023 | Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0780-2023 | 04-26-2023 | Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0779-2023 | 04-26-2023 | Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0797-2023 | 04-26-2023 | Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0855-2023 | 04-26-2023 | Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0838-2023 | 04-26-2023 | Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0832-2023 | 04-26-2023 | Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0844-2023 | 04-26-2023 | Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0818-2023 | 04-26-2023 | Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0573-2023 | 04-26-2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7. | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Gadget Island, Inc / 140 blister packs | Class I | Ongoing |
| D-0571-2023 | 04-26-2023 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0. | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Gadget Island, Inc / 628 blister cards | Class I | Ongoing |
| D-0572-2023 | 04-26-2023 | NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3. | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Gadget Island, Inc / 18 blister cards | Class I | Ongoing |
| D-0570-2023 | 04-24-2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61 Package NDCs: 0904-6823-61; 0904-7108-61 | Product mixup: one foreign tablet found in product. | The Harvard Drug Group / 3984 cartons | Class III | Terminated |
| D-0868-2023 | 04-20-2023 | G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01 Package NDCs: 52083-655-01 | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Novis PR, LLC dba Kramer Novis / 9077 bottles | Class I | Terminated |
| D-0556-2023 | 04-20-2023 | Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA Package NDCs: 63629-8755-2; 63629-8755-1; 63629-8755-20 | Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. | Bryant Ranch Prepack, Inc. / 403 boxes | Class III | Ongoing |
| D-0562-2023 | 04-19-2023 | Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471. | Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications | Seatex LLC / 2880 containers | Class II | Ongoing |
| D-0569-2023 | 04-19-2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1 Package NDCs: 55566-1010-1 | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Sun Pharmaceutical Industries Ltd. / 24194 Prefilled Syringes | Class II | Terminated |
| D-0546-2023 | 04-13-2023 | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 93,660 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0545-2023 | 04-13-2023 | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 320,350 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0547-2023 | 04-13-2023 | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 23,060 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0538-2023 | 04-13-2023 | C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402 | Lack of assurance of sterility. | Pharmacy Plus, Inc. dba Vital Care Compounder / 45 vials | Class II | Ongoing |
| D-0544-2023 | 04-13-2023 | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 464,050 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0575-2023 | 04-11-2023 | Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05 Package NDCs: 0024-5924-10; 0024-5925-01; 0024-5925-05; 0024-5925-00; 0024-5926-05 | Lack of Assurance of Sterility: Malformed crimped collar seal | Sanofi-Aventis U.S. LLC / 51,325 vials | Class II | Ongoing |
| D-0555-2023 | 04-10-2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44 | Subpotent Drug: Out of specification results for low potency was obtained. | SCA Pharmaceuticals / 73,312 containers | Class III | Terminated |
| D-0540-2023 | 04-07-2023 | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial). | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures. | Methapharm Inc / 5377 cartons | Class II | Completed |
| D-0537-2023 | 04-06-2023 | Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8. | CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. | Pharma Nobis LLC / 69,615 bottles | Class II | Ongoing |
| D-0561-2023 | 04-06-2023 | Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90) | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 393 bottles | Class II | Terminated |
| D-0559-2023 | 04-06-2023 | Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90 | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 186 bottles | Class II | Terminated |
| D-0558-2023 | 04-06-2023 | Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90) | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 37 bottles | Class II | Terminated |
| D-0557-2023 | 04-06-2023 | Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30 | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 352 bottles | Class II | Terminated |
| D-0560-2023 | 04-06-2023 | Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90) | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 520 bottles | Class II | Terminated |
| D-0564-2023 | 03-31-2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / Pending | Class II | Ongoing |
| D-0566-2023 | 03-31-2023 | Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles. | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / Pending | Class II | Ongoing |
| D-0565-2023 | 03-31-2023 | Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / | Class II | Ongoing |
| D-0563-2023 | 03-31-2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets. | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / Pending. | Class II | Ongoing |
| D-0529-2023 | 03-29-2023 | Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512. Package NDCs: 47335-615-44; 47335-615-40 | Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring. | SUN PHARMACEUTICAL INDUSTRIES INC / 16,450 vials | Class III | Terminated |
| D-0528-2023 | 03-29-2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08. | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Accord Healthcare, Inc. / 4574 cartons | Class III | Terminated |
| D-0872-2023 | 03-27-2023 | Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01 | CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products. | Jarman's Midwest Cleaning Systems, Inc. / 1276 gallons | Class II | Terminated |
| D-0874-2023 | 03-27-2023 | SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. | Chemical Contamination: FDA testing found Presence of methanol | Jarman's Midwest Cleaning Systems, Inc. / 7303 gallons | Class I | Terminated |
| D-0873-2023 | 03-27-2023 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. | Chemical Contamination: FDA testing found Presence of methanol | Jarman's Midwest Cleaning Systems, Inc. / 2365 gallons | Class I | Terminated |
| D-0531-2023 | 03-27-2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1 | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Pine Pharmaceuticals, LLC / 932 syringes | Class III | Terminated |
| D-0510-2023 | 03-27-2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19 | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Teva Pharmaceuticals USA Inc / 3,772 cartons | Class III | Terminated |
| D-0505-2023 | 03-27-2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. / 320 x 30-count; 46 x 60-count; 10 x 90-count bottles | Class II | Terminated |
| D-0504-2023 | 03-27-2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3 | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. / 30 Bottles | Class II | Terminated |
| D-0506-2023 | 03-27-2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. / 33 x 30-count; 78 x 60-count bottles | Class II | Terminated |
| D-0521-2023 | 03-23-2023 | Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 24 Bottles | Class II | Ongoing |
| D-0514-2023 | 03-23-2023 | Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 3 Bottles | Class II | Ongoing |
| D-0515-2023 | 03-23-2023 | Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 4 Bottles | Class II | Ongoing |
| D-0512-2023 | 03-23-2023 | Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 375 Bottles b) 323 Bottles | Class II | Ongoing |
| D-0511-2023 | 03-23-2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 158 Bottles | Class II | Ongoing |
| D-0513-2023 | 03-23-2023 | Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 72 Bottles | Class II | Ongoing |
| D-0520-2023 | 03-23-2023 | Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 264 Bottles | Class II | Ongoing |
| D-0516-2023 | 03-23-2023 | Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 135 Bottles, b) 24 Bottles | Class II | Ongoing |
| D-0527-2023 | 03-23-2023 | Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 15 Bottles | Class II | Ongoing |
| D-0517-2023 | 03-23-2023 | Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 17 Bottles | Class II | Ongoing |
| D-0523-2023 | 03-23-2023 | Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 57 Bottles | Class II | Ongoing |
| D-0524-2023 | 03-23-2023 | Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 305 Bottles, b) 72 Bottles, c) 617 Bottles | Class II | Ongoing |
| D-0518-2023 | 03-23-2023 | Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 266 Bottles, b) not reported, c) 216 Bottles | Class II | Ongoing |
| D-0525-2023 | 03-23-2023 | Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 88 Bottles, b) 3 Bottles, c) 175 Bottles | Class II | Ongoing |
| D-0522-2023 | 03-23-2023 | Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 82 Bottles of 90 Tablets | Class II | Ongoing |
| D-0519-2023 | 03-23-2023 | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 59 Bottles, b) 77 Bottles | Class II | Ongoing |
| D-0526-2023 | 03-23-2023 | Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7 Package NDCs: 68788-8153-7 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 32 Bottles | Class II | Ongoing |
| D-0509-2023 | 03-22-2023 | Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60. | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx / 9 bottles | Class II | Ongoing |
| D-0508-2023 | 03-22-2023 | Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx / 349 bottles | Class II | Ongoing |
| D-0507-2023 | 03-22-2023 | Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30. | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx / 20 bottles | Class II | Ongoing |
| D-0498-2023 | 03-20-2023 | Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / 3,426 bottles | Class II | Terminated |
| D-0502-2023 | 03-20-2023 | Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 76 bottles, b)151 bottles | Class II | Terminated |
| D-0490-2023 | 03-20-2023 | Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03 | cGMP Deviations | RemedyRepack Inc. / 3 bottles | Class II | Terminated |
| D-0500-2023 | 03-20-2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00 | cGMP Deviations | RemedyRepack Inc. / 132 bottles | Class II | Terminated |
| D-0499-2023 | 03-20-2023 | Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00 | cGMP Deviations | RemedyRepack Inc. / 3 bottles | Class II | Terminated |
| D-0491-2023 | 03-20-2023 | Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 3,497 bottles, b) 729 bottles | Class II | Terminated |
| D-0497-2023 | 03-20-2023 | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00 | cGMP Deviations | RemedyRepack Inc. / 16 bottles | Class II | Terminated |
| D-0503-2023 | 03-20-2023 | Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 | cGMP Deviations | RemedyRepack Inc. / | Class II | Terminated |
| D-0495-2023 | 03-20-2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00. | cGMP Deviations | RemedyRepack Inc. / 399 bottles | Class II | Terminated |
| D-0494-2023 | 03-20-2023 | Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00. | cGMP Deviations | RemedyRepack Inc. / 17 bottles | Class II | Terminated |
| D-0492-2023 | 03-20-2023 | Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 58 bottles, b) 6 bottles | Class II | Terminated |
| D-0496-2023 | 03-20-2023 | Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 | cGMP Deviations | RemedyRepack Inc. / a) 1,262 bottles, b) 95 bottles | Class II | Terminated |
| D-0493-2023 | 03-20-2023 | Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 | cGMP Deviations | RemedyRepack Inc. / a) 147 bottles, b)70 bottles, c) 3 bottles | Class II | Terminated |
| D-0501-2023 | 03-20-2023 | Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 399 bottles, b)445 bottles | Class II | Terminated |
| D-0758-2023 | 03-17-2023 | Glimepiride 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC / 105,361 bottles | Class II | Terminated |
| D-0757-2023 | 03-17-2023 | Glimepiride 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC / 63,335 bottles | Class II | Terminated |
| D-0759-2023 | 03-17-2023 | Glimepiride 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC / 129,849 bottles | Class II | Terminated |
| D-0539-2023 | 03-17-2023 | Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05 Package NDCs: 67877-431-03; 67877-431-01; 67877-431-05; 67877-431-33; 67877-431-38; 67877-431-32; 67877-432-03; 67877-432-01; 67877-432-05; 67877-432-33; 67877-432-38; 67877-432-32; 67877-433-03; 67877-433-01; 67877-433-05; 67877-433-33; 67877-433-38; 67877-433-32; 67877-434-03; 67877-434-01; 67877-434-05; 67877-434-33; 67877-434-38; 67877-435-03; 67877-435-01; 67877-435-05; 67877-435-33; 67877-435-38; 67877-430-03; 67877-430-01; 67877-430-05; 67877-430-33; 67877-430-38; 67877-430-32 | Out of specification (OOS) for Spectroscopic Identification test by IR. | Ascend Laboratories, LLC / 135 bottles | Class II | Ongoing |
| D-0554-2023 | 03-16-2023 | Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52 Package NDCs: 51655-487-52 | CGMP Deviations | Northwind Pharmaceuticals LLC / 23 bottles | Class II | Ongoing |
| D-0548-2023 | 03-16-2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52 Package NDCs: 51655-946-52 | CGMP Deviations | Northwind Pharmaceuticals LLC / 99 bottles | Class II | Ongoing |
