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 September 05, 2025 and include a total of 17050 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0504-2022 | 01-24-2022 | PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. | cGMP deviations | Ultra Seal Corporation / a) 156,096 packets, b) 9,648 bottles | Class II | Terminated |
| D-0509-2022 | 01-24-2022 | FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | cGMP deviations | Ultra Seal Corporation / 223,090 packets | Class II | Terminated |
| D-0485-2022 | 01-24-2022 | Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040 | cGMP deviations | Ultra Seal Corporation / 1,186,000 packets | Class II | Terminated |
| D-0472-2022 | 01-24-2022 | DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270 | cGMP deviations | Ultra Seal Corporation / a) 147,528 bottles, b) 2,451 bottles, c) 2,492 bottles, d) 573,696 packets | Class II | Terminated |
| D-0514-2022 | 01-24-2022 | MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | cGMP deviations | Ultra Seal Corporation / 409,890 packets | Class II | Terminated |
| D-0469-2022 | 01-24-2022 | Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc. | cGMP deviations | Ultra Seal Corporation / 297,050 packets | Class II | Terminated |
| D-0510-2022 | 01-24-2022 | CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | cGMP deviations | Ultra Seal Corporation / 225,000 packets | Class II | Terminated |
| D-0478-2022 | 01-24-2022 | Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | cGMP deviations | Ultra Seal Corporation / 673,160 packets | Class II | Terminated |
| D-0474-2022 | 01-24-2022 | Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02 | cGMP deviations | Ultra Seal Corporation / a) 9,060 bottles, b) 44,700 packets | Class II | Terminated |
| D-0467-2022 | 01-24-2022 | Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68 | cGMP deviations | Ultra Seal Corporation / 1,236,000 packets | Class II | Terminated |
| D-0481-2022 | 01-24-2022 | Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040 | cGMP deviations | Ultra Seal Corporation / 1,351,660 packets | Class II | Terminated |
| D-0489-2022 | 01-24-2022 | SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00 | cGMP deviations | Ultra Seal Corporation / 122,400 packets | Class II | Terminated |
| D-0506-2022 | 01-24-2022 | MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6 | cGMP deviations | Ultra Seal Corporation / 90,072 bottles | Class II | Terminated |
| D-0473-2022 | 01-24-2022 | Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24 | cGMP deviations | Ultra Seal Corporation / 301,842 bottles | Class II | Terminated |
| D-0483-2022 | 01-24-2022 | Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03 | cGMP deviations | Ultra Seal Corporation / 7,858,690 packets | Class II | Terminated |
| D-0493-2022 | 01-24-2022 | PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00 | cGMP deviations | Ultra Seal Corporation / 111,300 packets | Class II | Terminated |
| D-0470-2022 | 01-24-2022 | Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50 | cGMP deviations | Ultra Seal Corporation / 174,852 bottles | Class II | Terminated |
| D-0477-2022 | 01-24-2022 | Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | cGMP deviations | Ultra Seal Corporation / 915,770 packets | Class II | Terminated |
| D-0494-2022 | 01-24-2022 | PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03 | cGMP deviations | Ultra Seal Corporation / 769,200 packets | Class II | Terminated |
| D-0475-2022 | 01-24-2022 | MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA | cGMP deviations | Ultra Seal Corporation / 2,189,232 bottles | Class II | Terminated |
| D-0496-2022 | 01-24-2022 | Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68 | cGMP deviations | Ultra Seal Corporation / 1,309,800 packets | Class II | Terminated |
| D-0487-2022 | 01-24-2022 | COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556 | cGMP deviations | Ultra Seal Corporation / 226,400 packets | Class II | Terminated |
| D-0502-2022 | 01-24-2022 | PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. | cGMP deviations | Ultra Seal Corporation / a)131,112 packets, b) 8,064 bottles | Class II | Terminated |
| D-0465-2022 | 01-24-2022 | Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040 | cGMP deviations | Ultra Seal Corporation / 313,000 packets | Class II | Terminated |
| D-0488-2022 | 01-24-2022 | PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507 | cGMP deviations | Ultra Seal Corporation / 1,188,280 packets | Class II | Terminated |
| D-0486-2022 | 01-24-2022 | Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040 | cGMP deviations | Ultra Seal Corporation / 301,650 packets | Class II | Terminated |
| D-0501-2022 | 01-24-2022 | PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060. | cGMP deviations | Ultra Seal Corporation / N/A | Class II | Terminated |
| D-0491-2022 | 01-24-2022 | EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03 | cGMP deviations | Ultra Seal Corporation / 1,694,200 packets | Class II | Terminated |
| D-0497-2022 | 01-24-2022 | Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68 | cGMP deviations | Ultra Seal Corporation / 887,000 packets | Class II | Terminated |
| D-0471-2022 | 01-24-2022 | Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40 Package NDCs: 69693-512-40; 69693-512-20; 69693-512-24; 69693-512-48 | cGMP deviations | Ultra Seal Corporation / a) 702,240 blisters, b) 30,180 blisters | Class II | Terminated |
| D-0452-2022 | 01-21-2022 | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10. Package NDCs: 0037-6822-10 | cGMP deficiencies | Mylan Pharmaceuticals Inc / 233,199/10 g aerosol containers | Class II | Terminated |
| D-0577-2022 | 01-19-2022 | Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60 | Failed stability specifications | Dr. Reddy's Laboratories, Inc. / 2,980 vials | Class III | Terminated |
| D-0576-2022 | 01-19-2022 | Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62 Package NDCs: 43598-465-62 | Failed stability specifications | Dr. Reddy's Laboratories, Inc. / 18261 vials | Class III | Terminated |
| D-0575-2022 | 01-19-2022 | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62 Package NDCs: 43598-305-62 | Failed stability specifications | Dr. Reddy's Laboratories, Inc. / 68061 vials | Class III | Terminated |
| D-0461-2022 | 01-18-2022 | Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01 Package NDCs: 0591-2132-01 | Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient | Teva Pharmaceuticals USA / 6205 100-count bottles | Class II | Terminated |
| D-0387-2022 | 01-14-2022 | Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50 | CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. | Mayne Pharma Inc / 17,113 canisters | Class II | Ongoing |
| D-0560-2022 | 01-14-2022 | Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03 Package NDCs: 65862-840-03 | Failed Impurities/Degradation Specifications | Aurobindo Pharma USA Inc. / 115776 bottles | Class II | Terminated |
| D-0393-2022 | 01-12-2022 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specifications. | Ascend Laboratories, LLC / 9216 bottles | Class II | Terminated |
| D-0369-2022 | 01-11-2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1 | Lack of Assurance of Sterility | Exela Pharma Sciences LLC / 18,960 vials | Class II | Terminated |
| D-0574-2022 | 01-11-2022 | Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302 | cGMP deviations | Pharmasol Corporation / 5,004 cans of propellent | Class II | Terminated |
| D-0388-2022 | 01-10-2022 | Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / 18336 cartons | Class III | Terminated |
| D-0374-2022 | 01-10-2022 | Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408. | CGMP Deviations | Ingenus Pharmaceuticals Llc / 45,173 cans | Class II | Terminated |
| D-0520-2022 | 01-10-2022 | Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02 | Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. | Teva Pharmaceuticals USA / 1,175 Bottles | Class II | Terminated |
| D-0376-2022 | 01-07-2022 | Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04 | Failed Stability Specifications | VistaPharm, Inc. / 18,456 bottles | Class II | Terminated |
| D-0521-2022 | 01-07-2022 | Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28 Package NDCs: 0093-5455-28; 0093-5455-42 | Mislabeling | Teva Pharmaceuticals USA / 218174 cartons | Class III | Terminated |
| D-0522-2022 | 01-07-2022 | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42 Package NDCs: 0093-5455-28; 0093-5455-42 | Mislabeling | Teva Pharmaceuticals USA / 6430 cartons | Class III | Terminated |
| D-0462-2022 | 01-05-2022 | Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505. | Labeling: Missing Label: label missing from some Semglee prefilled pens. | Mylan Pharmaceuticals Inc / 73,175 prefilled pens | Class I | Terminated |
| D-0460-2022 | 01-05-2022 | Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02. | Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. | Akorn, Inc. / 31,510 ampules | Class II | Terminated |
| D-0385-2022 | 01-04-2022 | CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 41,784 boxes | Class III | Terminated |
| D-0378-2022 | 01-04-2022 | Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India. Package NDCs: 0363-1606-30; 0363-1606-20 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 67,848 boxes | Class III | Terminated |
| D-0380-2022 | 01-04-2022 | Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 7,080 boxes | Class III | Terminated |
| D-0382-2022 | 01-04-2022 | Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 9,912 boxes | Class III | Terminated |
| D-0381-2022 | 01-04-2022 | Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India. Package NDCs: 30142-611-14 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 11,064 boxes | Class III | Terminated |
| D-0384-2022 | 01-04-2022 | QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 9,984 boxes | Class III | Terminated |
| D-0383-2022 | 01-04-2022 | equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India. Package NDCs: 49035-273-20; 49035-273-30 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 137,856 boxes | Class III | Terminated |
| D-0386-2022 | 01-04-2022 | Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India. Package NDCs: 70000-0518-1; 70000-0518-2 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 10,536 boxes | Class III | Terminated |
| D-0379-2022 | 01-04-2022 | Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India. Package NDCs: 0536-1242-34; 0536-1242-07 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 2,352 boxes | Class III | Terminated |
| D-0362-2022 | 12-31-2021 | Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00 Package NDCs: 52817-362-10; 52817-362-00; 52817-359-10; 52817-359-50; 52817-361-10; 52817-361-00; 52817-360-10; 52817-360-00; 52817-358-10; 52817-358-50 | Complaint received of foreign matter (metal) embedded in tablet. | Rubicon Research Private Limited / 3,684 1000-count bottles | Class II | Terminated |
| D-0371-2022 | 12-31-2021 | Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 11,450 vials | Class II | Terminated |
| D-0370-2022 | 12-31-2021 | MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 7,400 cartons | Class II | Terminated |
| D-0366-2022 | 12-30-2021 | Metformin 750 mg Extended Release NDC # 70518-2920-00 | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | RemedyRepack Inc. / 56 Blister Cards | Class II | Terminated |
| D-0360-2022 | 12-29-2021 | Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645 | Failed Impurities/Degradation Specifications | RemedyRepack Inc. / a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules | Class II | Terminated |
| D-0450-2022 | 12-29-2021 | Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05 Package NDCs: 57237-219-30; 57237-219-90; 57237-219-05; 57237-220-30; 57237-220-90; 57237-220-05; 57237-221-30; 57237-221-90; 57237-221-05 | Superpotent and Failed Tablet/Capsule Specifications | Aurobindo Pharma USA Inc. / 792 bottles | Class II | Terminated |
| D-0358-2022 | 12-29-2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01 Package NDCs: 43386-432-01; 43386-432-03; 43386-432-05; 43386-433-01; 43386-433-03; 43386-433-05; 43386-430-01; 43386-430-05; 43386-430-03; 43386-434-01; 43386-434-05; 43386-434-03; 43386-431-01; 43386-431-03; 43386-431-05 | Out-of-specification impurity test result observed at 18-month long term stability time point. | Lupin Pharmaceuticals Inc. / 23,965 100 count bottles | Class III | Terminated |
| D-0372-2022 | 12-27-2021 | Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02 Package NDCs: 45802-210-01; 45802-210-02 | Defective Delivery System | Padagis US LLC / 11,868 bottles | Class II | Terminated |
| D-0392-2022 | 12-27-2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01 Package NDCs: 72578-035-01; 72578-035-05; 72578-036-01; 72578-036-05 | CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | VIONA PHARMACEUTICALS INC / 23,8416/100 count bottles | Class II | Terminated |
| D-0326-2022 | 12-22-2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. | Lupin Pharmaceuticals Inc. / 50,832 bottles | Class III | Terminated |
| D-0463-2022 | 12-21-2021 | Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083 | Lack of Assurance of Sterility | Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy / 57,994 vials | Class II | Ongoing |
| D-0377-2022 | 12-21-2021 | SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24. | Microbial Contamination of Non-Sterile Product | Lohxa, LLC / 87,840 unit dose cups | Class I | Terminated |
| D-0359-2022 | 12-21-2021 | Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50 Package NDCs: 67877-584-50; 67877-584-01; 67877-584-05; 67877-584-33 | Failed impurities/degradation specifications | Ascend Laboratories, LLC / 42,698 bottles | Class II | Terminated |
| D-0451-2022 | 12-20-2021 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03 Package NDCs: 68001-500-00; 68001-500-03; 68001-500-08; 68001-501-00; 68001-501-03; 68001-501-08; 68001-502-00; 68001-502-03; 68001-502-08; 68001-503-00 | Failed Dissolution Specifications | American Health Packaging / 6,637 500-count bottles | Class II | Terminated |
| D-0294-2022 | 12-16-2021 | Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 | Subpotent | Teva Pharmaceuticals USA / a) 86,790 and b) 25,416 bottles | Class II | Terminated |
| D-0375-2022 | 12-15-2021 | Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3 Package NDCs: 51672-1294-1; 51672-1294-2; 51672-1294-3; 51672-1258-1; 51672-1258-2; 51672-1258-6; 51672-1258-3; 51672-1259-1; 51672-1259-2; 51672-1259-6; 51672-1259-3 | Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria | Taro Pharmaceuticals U.S.A., Inc. / 96 tubes | Class I | Terminated |
| D-0373-2022 | 12-08-2021 | Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ Package NDCs: 0591-2127-79; 0591-2127-12 | Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing. | Teva Pharmaceuticals USA / a) 66,099 dropper bottles; b) 21,243 dropper bottles | Class II | Terminated |
| D-0714-2022 | 12-07-2021 | Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05 | Defective Container: Leaking containers. | Direct Rx / 312 bottles | Class II | Terminated |
| D-0559-2022 | 12-06-2021 | NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae. | Organics Corporation of America DBA Ambix Laboratories / 4,214 tubes | Class II | Ongoing |
| D-0391-2022 | 12-06-2021 | Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404 | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. | Medique Products / 6,639,838 tablets | Class II | Terminated |
| D-0390-2022 | 12-06-2021 | Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967. | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. | Medique Products / 16,630,118 tablets | Class II | Terminated |
| D-0389-2022 | 12-06-2021 | Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6 | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. | Medique Products / 3,260,400 tablets | Class II | Terminated |
| D-0434-2022 | 12-06-2021 | Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03 | CGMP Deviations | Edge Pharma, LLC / 63 vials | Class II | Terminated |
| D-0420-2022 | 12-06-2021 | Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 363 droptainers | Class II | Terminated |
| D-0415-2022 | 12-06-2021 | Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05 | Lack of Assurance of Sterility | Edge Pharma, LLC / 3747 syringes | Class II | Terminated |
| D-0436-2022 | 12-06-2021 | LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01 | CGMP Deviations | Edge Pharma, LLC / 74 jars | Class II | Terminated |
| D-0444-2022 | 12-06-2021 | Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03 | CGMP Deviations | Edge Pharma, LLC / 231 bottles | Class II | Terminated |
| D-0429-2022 | 12-06-2021 | Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03 | CGMP Deviations | Edge Pharma, LLC / 1173 vials | Class II | Terminated |
| D-0421-2022 | 12-06-2021 | Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 2562 syringes | Class II | Terminated |
| D-0449-2022 | 12-06-2021 | Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01 | CGMP Deviations | Edge Pharma, LLC / | Class II | Terminated |
| D-0432-2022 | 12-06-2021 | CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01 | CGMP Deviations | Edge Pharma, LLC / 440 cartons | Class II | Terminated |
| D-0425-2022 | 12-06-2021 | Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1795 bags | Class II | Terminated |
| D-0416-2022 | 12-06-2021 | Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10 | Lack of Assurance of Sterility | Edge Pharma, LLC / 6535 vials | Class II | Terminated |
| D-0395-2022 | 12-06-2021 | Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10 | Lack of Assurance of Sterility | Edge Pharma, LLC / 4465 syringes | Class II | Terminated |
| D-0440-2022 | 12-06-2021 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10 | CGMP Deviations | Edge Pharma, LLC / 221 jars | Class II | Terminated |
| D-0411-2022 | 12-06-2021 | Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05 | Lack of Assurance of Sterility | Edge Pharma, LLC / 160 syringes | Class II | Terminated |
| D-0430-2022 | 12-06-2021 | Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03 | CGMP Deviations | Edge Pharma, LLC / 2204 vials | Class II | Terminated |
| D-0448-2022 | 12-06-2021 | Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01 | CGMP Deviations | Edge Pharma, LLC / 6925 syringes | Class II | Terminated |
| D-0422-2022 | 12-06-2021 | Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03 | Lack of Assurance of Sterility | Edge Pharma, LLC / 40 droptainers | Class II | Terminated |
| D-0414-2022 | 12-06-2021 | Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 2463 vials | Class II | Terminated |
| D-0423-2022 | 12-06-2021 | Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1773 syringes | Class II | Terminated |
| D-0427-2022 | 12-06-2021 | Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 749 bags | Class II | Terminated |
| D-0441-2022 | 12-06-2021 | Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10 | CGMP Deviations | Edge Pharma, LLC / 418 jars | Class II | Terminated |
