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-0556-2022 | 01-26-2022 | Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10 Package NDCs: 55150-234-10 | Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot | AuroMedics Pharma LLC / 35,520 vials | Class I | Terminated |
| D-0177-2024 | 01-26-2022 | Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09 Package NDCs: 43547-275-03; 43547-275-09; 43547-275-11; 43547-276-03; 43547-276-09; 43547-276-11 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0189-2024 | 01-26-2022 | Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0180-2024 | 01-26-2022 | ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02 Package NDCs: 0555-0899-02; 0555-0886-02; 0555-0886-04; 0555-0887-02; 0555-0887-04 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0165-2024 | 01-26-2022 | AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73 Package NDCs: 0093-2263-01; 0093-2264-01; 0093-4160-76; 0093-4160-78; 0093-4160-73; 0093-4155-79; 0093-4155-73; 0093-4155-80; 0093-4161-76; 0093-4161-78; 0093-4161-73; 0093-2267-01; 0093-2268-01; 0093-3107-01; 0093-3107-05; 0093-3109-53; 0093-3109-05 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 3 units | Class II | Terminated |
| D-0197-2024 | 01-26-2022 | SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41 Package NDCs: 0597-0075-41; 0597-0075-75; 0597-0075-47 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 5 units | Class II | Terminated |
| D-0167-2024 | 01-26-2022 | Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03 Package NDCs: 65162-896-03; 65162-896-09; 65162-896-50; 65162-896-11; 65162-897-03; 65162-897-09; 65162-897-50; 65162-897-11; 65162-898-03; 65162-898-09; 65162-898-50; 65162-898-11; 65162-899-03; 65162-899-09; 65162-899-50; 65162-899-11; 65162-901-03; 65162-901-09; 65162-901-50; 65162-901-11; 65162-902-03; 65162-902-09; 65162-902-50; 65162-902-11 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0162-2024 | 01-26-2022 | ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68 Package NDCs: 66993-019-68 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 cartons | Class II | Terminated |
| D-0170-2024 | 01-26-2022 | Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41 Package NDCs: 0536-1234-41 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0169-2024 | 01-26-2022 | Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01 Package NDCs: 78206-114-03; 78206-114-04; 78206-114-02; 78206-114-01; 78206-114-59; 78206-115-59; 78206-115-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 3 units | Class II | Terminated |
| D-0185-2024 | 01-26-2022 | Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37 Package NDCs: 0597-0152-90; 0597-0152-07; 0597-0152-70; 0597-0152-37; 0597-0152-30; 0597-0153-37; 0597-0153-30; 0597-0153-90; 0597-0153-07; 0597-0153-70 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0194-2024 | 01-26-2022 | Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1 Package NDCs: 69238-2077-1; 69238-2077-7; 69238-2078-1; 69238-2078-7; 69238-2079-1; 69238-2079-7; 69238-2080-1; 69238-2081-1; 69238-2081-5 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0193-2024 | 01-26-2022 | PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0166-2024 | 01-26-2022 | AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20 Package NDCs: 0781-2020-31; 0781-2020-76; 0781-2020-01; 0781-2020-05; 0781-2613-31; 0781-2613-76; 0781-2613-01; 0781-2613-05; 0781-5060-20; 0781-5060-01; 0781-5061-20; 0781-5061-01; 0781-6039-58; 0781-6039-46; 0781-6039-55; 0781-6156-52; 0781-6156-57; 0781-6156-46; 0781-6041-58; 0781-6041-46; 0781-6041-55; 0781-6157-52; 0781-6157-57; 0781-6157-46 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0186-2024 | 01-26-2022 | Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0202-2024 | 01-26-2022 | Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32 Package NDCs: 0378-9320-32; 0378-9321-32; 0378-9322-32 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0164-2024 | 01-26-2022 | ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05 Package NDCs: 55111-729-01; 55111-729-10; 55111-730-01; 55111-730-05 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0191-2024 | 01-26-2022 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96 Package NDCs: 45963-709-11; 45963-709-96; 45963-676-11; 45963-676-96; 45963-677-11; 45963-677-96; 45963-678-11 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0188-2024 | 01-26-2022 | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01 Package NDCs: 68180-518-02; 68180-518-01; 68180-518-30; 68180-519-30; 68180-519-01; 68180-519-02; 68180-520-02; 68180-520-30; 68180-520-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0168-2024 | 01-26-2022 | ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0161-2024 | 01-26-2022 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64 Package NDCs: 69097-840-34; 69097-840-53; 69097-840-87; 69097-840-64 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 cartons | Class II | Terminated |
| D-0198-2024 | 01-26-2022 | Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73 Package NDCs: 0713-0552-73 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0175-2024 | 01-26-2022 | Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01 Package NDCs: 0591-0794-01; 0591-0794-10; 0591-0795-01; 0591-0795-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0182-2024 | 01-26-2022 | Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 6 units | Class II | Terminated |
| D-0184-2024 | 01-26-2022 | HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0668-2022 | 01-25-2022 | REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670 Package NDCs: 63347-120-01; 63347-120-02 | Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus. | Blaine Labs Inc / 1119 (1 oz.) bottles/ 772 (3 oz.) tubes | Class I | Terminated |
| D-0508-2022 | 01-24-2022 | Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | cGMP deviations | Ultra Seal Corporation / 1,486,050 packets | Class II | Terminated |
| D-0515-2022 | 01-24-2022 | ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | cGMP deviations | Ultra Seal Corporation / 1,474,050 packets | Class II | Terminated |
| D-0512-2022 | 01-24-2022 | AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | cGMP deviations | Ultra Seal Corporation / 216,000 packets | Class II | Terminated |
| D-0513-2022 | 01-24-2022 | SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917 | cGMP deviations | Ultra Seal Corporation / 448,300 packets | Class II | Terminated |
| D-0466-2022 | 01-24-2022 | AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 | cGMP deviations | Ultra Seal Corporation / 226,390 packets | Class II | Terminated |
| D-0505-2022 | 01-24-2022 | CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895 | cGMP deviations | Ultra Seal Corporation / 241,560 bottles | Class II | Terminated |
| D-0484-2022 | 01-24-2022 | Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02 | cGMP deviations | Ultra Seal Corporation / 5,741,384 packets | Class II | Terminated |
| D-0519-2022 | 01-24-2022 | Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 | cGMP deviations | Ultra Seal Corporation / 227,010 packets | Class II | Terminated |
| D-0495-2022 | 01-24-2022 | CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040 | cGMP deviations | Ultra Seal Corporation / 447,050 packets | Class II | Terminated |
| D-0511-2022 | 01-24-2022 | CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124 | cGMP deviations | Ultra Seal Corporation / 1,019,000 packets | Class II | Terminated |
| D-0482-2022 | 01-24-2022 | Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832 | cGMP deviations | Ultra Seal Corporation / 5,107,565 packets | Class II | Terminated |
| D-0464-2022 | 01-24-2022 | Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040 | cGMP deviations | Ultra Seal Corporation / 3,508,200 packets | Class II | Terminated |
| D-0490-2022 | 01-24-2022 | DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03 | cGMP deviations | Ultra Seal Corporation / 2,685,700 packets | Class II | Terminated |
| D-0499-2022 | 01-24-2022 | PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423 | cGMP deviations | Ultra Seal Corporation / 533,100 packets | Class II | Terminated |
| D-0468-2022 | 01-24-2022 | CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2 | cGMP deviations | Ultra Seal Corporation / 225,350 packets | Class II | Terminated |
| D-0492-2022 | 01-24-2022 | PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040 | cGMP deviations | Ultra Seal Corporation / 2,336,600 packets | Class II | Terminated |
| D-0479-2022 | 01-24-2022 | Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487 | cGMP deviations | Ultra Seal Corporation / 25,776 blisters | Class II | Terminated |
| D-0498-2022 | 01-24-2022 | Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00 | cGMP deviations | Ultra Seal Corporation / 1,180,000 packets | Class II | Terminated |
| D-0503-2022 | 01-24-2022 | PEPTIME Energy (caffeine 350mg) 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) 113,040 packets, b) 7,132 bottles | Class II | Terminated |
| D-0516-2022 | 01-24-2022 | REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487 | cGMP deviations | Ultra Seal Corporation / a) 308,928 blisters b) 29,808 blisters | Class II | Terminated |
| D-0518-2022 | 01-24-2022 | Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 | cGMP deviations | Ultra Seal Corporation / 447,190 packets | Class II | Terminated |
| D-0500-2022 | 01-24-2022 | MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423 | cGMP deviations | Ultra Seal Corporation / 307,000 packets | Class II | Terminated |
| D-0476-2022 | 01-24-2022 | Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00 | cGMP deviations | Ultra Seal Corporation / 1,959,267 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-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-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-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-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-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-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-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-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-0517-2022 | 01-24-2022 | REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487 | cGMP deviations | Ultra Seal Corporation / 40,344 blisters | Class II | Terminated |
| D-0480-2022 | 01-24-2022 | Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007 | cGMP deviations | Ultra Seal Corporation / 227,010 packets | Class II | Terminated |
| 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-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-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-0507-2022 | 01-24-2022 | Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124 | cGMP deviations | Ultra Seal Corporation / 1,1401,641 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-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-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-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-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-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-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-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-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-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-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-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-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 | Failed Impurities/Degradation Specifications | Aurobindo Pharma USA Inc. / 115776 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-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-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-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-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 |
