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-0750-2022 | 03-04-2022 | Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047 Package NDCs: 63323-032-04; 63323-032-00 | Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose. | Fresenius Kabi USA, LLC / 118,040 vials | Class I | Terminated |
| D-0740-2022 | 03-03-2022 | HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01 | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Tennessee Technical Coatings, Corp. / N/A | Class II | Terminated |
| D-0739-2022 | 03-03-2022 | HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01 | Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol. | Tennessee Technical Coatings, Corp. / 169.2 gallons | Class I | Terminated |
| D-0654-2022 | 03-02-2022 | Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18. | CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process. | Golden State Medical Supply Inc. / 401 bottles | Class II | Terminated |
| D-0644-2022 | 03-02-2022 | HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7 | Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles. | Vi-Jon, Inc. / 11,580 bottles | Class II | Terminated |
| D-0649-2022 | 02-28-2022 | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61 Package NDCs: 0904-6935-61; 0904-6936-61; 0904-6937-61 | Failed Dissolution Specifications | The Harvard Drug Group / 174 cartons | Class II | Terminated |
| D-0727-2022 | 02-25-2022 | Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1 Package NDCs: 51672-4048-1; 51672-4048-6 | Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample | Taro Pharmaceuticals U.S.A., Inc. / 768 tubes | Class III | Terminated |
| D-0655-2022 | 02-25-2022 | 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20 Package NDCs: 0264-7800-00; 0264-7800-10; 0264-7800-20; 0264-7802-00; 0264-7802-10 | Lack of sterility assurance: leaking bags | B. Braun Medical, Inc. / 33,742 bags | Class II | Terminated |
| D-0653-2022 | 02-24-2022 | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61 | Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities. | The Harvard Drug Group / 5,953 cartons | Class II | Terminated |
| D-0652-2022 | 02-22-2022 | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40 Package NDCs: 60687-406-40; 60687-406-46; 60687-406-77; 60687-406-67 | Impurity failure at 0-time of the repackaged lot. | American Health Packaging / 89,880 unit-dose cups | Class II | Terminated |
| D-0642-2022 | 02-22-2022 | Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical. | CGMP deviations | Preferred Pharmaceuticals, Inc. / 276 bottles | Class II | Terminated |
| D-0713-2022 | 02-21-2022 | Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08. | Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product. | Morton Grove Pharmaceuticals, Inc. / | Class II | Terminated |
| D-0641-2022 | 02-18-2022 | All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. | CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. | Dollar Tree Distribution, Inc. / Unknown | Class II | Ongoing |
| D-0637-2022 | 02-17-2022 | Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05 | Failed impurities/degradation specifications | Direct Rx / 44 bottles | Class II | Terminated |
| D-0640-2022 | 02-17-2022 | Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton). | Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg. | Dr. Reddy's Laboratories, Inc. / 340 packets | Class III | Terminated |
| D-0208-2024 | 02-16-2022 | Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06 | Chemical contamination: Presence of benzene | TCP HRB ACQUISITON LLC / 0.5 million | Class I | Ongoing |
| D-0209-2024 | 02-16-2022 | Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06 | Chemical contamination: Presence of benzene | TCP HRB ACQUISITON LLC / 5.4 million | Class I | Ongoing |
| D-0207-2024 | 02-16-2022 | Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA | Chemical contamination: Presence of benzene | TCP HRB ACQUISITON LLC / a) 0.4 million cans, b) 3.4 million cans | Class I | Ongoing |
| D-0639-2022 | 02-16-2022 | Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07. Package NDCs: 33342-067-07; 33342-067-44; 33342-067-12; 33342-067-11; 33342-068-07; 33342-068-44; 33342-068-12; 33342-068-11; 33342-069-07; 33342-069-44; 33342-069-12; 33342-069-11; 33342-070-07; 33342-070-15; 33342-070-12; 33342-070-44; 33342-070-11; 33342-071-07; 33342-071-15; 33342-071-12; 33342-071-44; 33342-071-11; 33342-072-07; 33342-072-15; 33342-072-12; 33342-072-44; 33342-072-11 | cGmp Deviations | Macleods Pharma Usa Inc / 3672 bottles | Class II | Terminated |
| D-0632-2022 | 02-15-2022 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07. Package NDCs: 33342-190-07; 33342-190-10; 33342-190-12; 33342-190-44; 33342-191-07; 33342-191-10; 33342-191-12; 33342-191-44; 33342-192-07; 33342-192-10; 33342-192-12; 33342-192-44; 33342-193-07; 33342-193-10; 33342-193-12; 33342-193-44 | cGMP deviations | Macleods Pharma Usa Inc / 3,672 bottles | Class II | Terminated |
| D-0564-2022 | 02-15-2022 | Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | cGMP Deviations | ANI Pharmaceuticals, Inc. / 73,920 bottles | Class II | Terminated |
| D-0566-2022 | 02-15-2022 | Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | cGMP Deviations | ANI Pharmaceuticals, Inc. / 173,499 bottles | Class II | Terminated |
| D-0567-2022 | 02-15-2022 | Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | cGMP Deviations | ANI Pharmaceuticals, Inc. / 70,788 bottles | Class II | Terminated |
| D-0568-2022 | 02-15-2022 | Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10. | cGMP Deviations | ANI Pharmaceuticals, Inc. / 5,477 bottles | Class II | Terminated |
| D-0565-2022 | 02-15-2022 | Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | cGMP Deviations | ANI Pharmaceuticals, Inc. / 205,662 bottles | Class II | Terminated |
| D-0569-2022 | 02-14-2022 | Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392 | Subpotent drug | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy / 1157 bags | Class III | Terminated |
| D-0648-2022 | 02-11-2022 | HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01. | Non-sterility; bacterial contamination identified as Paenibacillus lautus. | Revive Rx LLC dba Revive Rx Pharmacy / 115 vials | Class I | Terminated |
| D-0645-2022 | 02-10-2022 | RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Positive Health / 5,500 cartons | Class I | Terminated |
| D-0558-2022 | 02-09-2022 | Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36. | Failed Impurities/Degradation Specifications: Out of specification results for related substances. | Lannett Company, Inc. / 23,598 bottles | Class II | Terminated |
| D-0725-2022 | 02-09-2022 | Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Walmart Stores / unknown | Class I | Terminated |
| D-0638-2022 | 02-08-2022 | RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Celebrate Today / 500 cartons | Class I | Terminated |
| D-0563-2022 | 02-08-2022 | MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764. | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs. | ABC Sales 1 Inc / 336 cartons | Class I | Terminated |
| D-0562-2022 | 02-08-2022 | MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191. | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs. | ABC Sales 1 Inc / 565 cartons | Class I | Terminated |
| D-0630-2022 | 02-08-2022 | THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Your Favorite Shop / 12,500 cartons | Class I | Terminated |
| D-0578-2022 | 02-07-2022 | Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88. Package NDCs: 57664-648-88; 57664-648-18; 57664-649-88; 57664-649-18 | Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup | SUN PHARMACEUTICAL INDUSTRIES INC / 59,232 bottles | Class II | Terminated |
| D-0716-2022 | 02-07-2022 | Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66. | Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds. | Teligent Pharma, Inc. / 11040 tubes | Class II | Terminated |
| D-0573-2022 | 02-07-2022 | Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01 Package NDCs: 64980-221-01; 64980-222-01; 64980-223-01 | Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind. | RISING PHARMACEUTICALS / 2220 100-count bottles | Class II | Ongoing |
| D-0636-2022 | 02-07-2022 | Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734. | Labeling - product contains undeclared ethyl alcohol | Tsm Brands LLC / 135.444 bottles | Class II | Ongoing |
| D-0635-2022 | 02-07-2022 | 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765 | Labeling - product contains undeclared ethyl alcohol | Tsm Brands LLC / 1.186.800 bottles | Class II | Ongoing |
| D-0571-2022 | 02-04-2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. Package NDCs: 10819-1080-1; 10819-1080-2 | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. | Professional Disposables International, Inc. / a) 160531 cases; b) 16123 cases | Class II | Terminated |
| D-0570-2022 | 02-04-2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. Package NDCs: 10819-4076-4; 10819-4076-3 | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. | Professional Disposables International, Inc. / a) 9518 cases; b) 3347 cases | Class II | Terminated |
| D-0572-2022 | 02-04-2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. Package NDCs: 10819-4077-1; 10819-4077-4; 10819-4077-2; 10819-4077-3 | cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. | Professional Disposables International, Inc. / a) 28201 cases; b) 7579 cases; c) 8882 cases | Class II | Terminated |
| D-0643-2022 | 02-04-2022 | PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01 | Non-sterility | CooperSurgical, Inc / 48,645 cartons | Class I | Terminated |
| D-0557-2022 | 02-04-2022 | MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88 | Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Junp Hydration LLC / 750 cartons | Class I | Terminated |
| D-0634-2022 | 02-03-2022 | Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04. | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A | STAQ Pharma, Inc. / n/a | Class I | Terminated |
| D-0633-2022 | 02-03-2022 | HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05. | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A | STAQ Pharma, Inc. / 905 Syringes | Class I | Terminated |
| D-0561-2022 | 01-28-2022 | HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59 | Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug. | Esupplementsales, LLC / 500 cartons | Class I | Terminated |
| D-0646-2022 | 01-28-2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ. | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. | AMS Packaging Inc / 2,095,567 bottles | Class II | Ongoing |
| D-0647-2022 | 01-28-2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ. | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. | AMS Packaging Inc / 487,000 bottles | Class II | Ongoing |
| D-0176-2024 | 01-26-2022 | Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09 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-0532-2022 | 01-26-2022 | Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 16,429,211 tablets | Class II | Terminated |
| D-0546-2022 | 01-26-2022 | Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 7,983,360 tablets | Class II | Terminated |
| D-0534-2022 | 01-26-2022 | Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 2,048,941 tablets | Class II | Terminated |
| D-0196-2024 | 01-26-2022 | RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0187-2024 | 01-26-2022 | Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0183-2024 | 01-26-2022 | FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10 Package NDCs: 69315-127-01; 69315-127-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0163-2024 | 01-26-2022 | ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01 Package NDCs: 68180-963-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 11 cartons | Class II | Terminated |
| D-0178-2024 | 01-26-2022 | Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08 Package NDCs: 68180-650-01; 68180-651-01; 68180-652-29; 68180-652-08 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0552-2022 | 01-26-2022 | Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 14,066,434 tablets | Class II | Terminated |
| D-0540-2022 | 01-26-2022 | Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 3,052,313 tablets | Class II | Terminated |
| D-0542-2022 | 01-26-2022 | Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 1,527,203 tablets | Class II | Terminated |
| D-0530-2022 | 01-26-2022 | APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 14,349,148 tablets | Class II | Terminated |
| D-0545-2022 | 01-26-2022 | Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 4,531,580 tablets | Class II | Terminated |
| D-0550-2022 | 01-26-2022 | Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 1,585,375 tablets | Class II | Terminated |
| D-0529-2022 | 01-26-2022 | APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 451,123 tablets | Class II | Terminated |
| D-0172-2024 | 01-26-2022 | CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10 Package NDCs: 43598-719-01; 43598-719-10; 43598-720-01; 43598-720-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0171-2024 | 01-26-2022 | Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0181-2024 | 01-26-2022 | FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0199-2024 | 01-26-2022 | Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0192-2024 | 01-26-2022 | Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447. | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0200-2024 | 01-26-2022 | Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01 Package NDCs: 0093-1712-01; 0093-1712-10; 0093-1713-01; 0093-1713-10; 0093-1714-01; 0093-1714-10; 0093-1715-01; 0093-1716-01; 0093-1716-10; 0093-1721-01; 0093-1721-10; 0093-1718-01; 0093-1723-01; 0093-1720-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0536-2022 | 01-26-2022 | APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 6,249,082 tablets | Class II | Terminated |
| D-0526-2022 | 01-26-2022 | Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 639,729 tablets | Class II | Terminated |
| D-0533-2022 | 01-26-2022 | Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 3,667,885 tablets | Class II | Terminated |
| D-0531-2022 | 01-26-2022 | APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 3,677,483 tablets | Class II | Terminated |
| D-0535-2022 | 01-26-2022 | Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 6,215,512 tablets | Class II | Terminated |
| D-0528-2022 | 01-26-2022 | Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 14,566,510 tablets | Class II | Terminated |
| D-0179-2024 | 01-26-2022 | Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69 Package NDCs: 0781-3238-01; 0781-3238-63; 0781-3246-02; 0781-3246-64; 0781-3256-03; 0781-3256-66; 0781-3262-04; 0781-3262-68; 0781-3268-05; 0781-3268-69; 0781-3298-04; 0781-3298-68; 0781-3299-05; 0781-3299-69 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0551-2022 | 01-26-2022 | Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 1,477,641 tablets | Class II | Terminated |
| D-0554-2022 | 01-26-2022 | DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 8,727,657 tablets | Class II | Terminated |
| D-0543-2022 | 01-26-2022 | Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 5,923,518 tablets | Class II | Terminated |
| D-0525-2022 | 01-26-2022 | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx | CGMP Deviations | ULTRAtab Laboratories, Inc. / 1,798,048 tablets | Class II | Terminated |
| D-0190-2024 | 01-26-2022 | Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15 Package NDCs: 69097-158-15; 69097-158-07; 69097-158-12; 69097-159-12; 69097-159-07; 69097-159-15 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0537-2022 | 01-26-2022 | APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 18,772,640 tablets | Class II | Terminated |
| D-0553-2022 | 01-26-2022 | Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 25,769,495 tablets | Class II | Terminated |
| D-0524-2022 | 01-26-2022 | 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 19,103,287 tablets | Class II | Terminated |
| D-0544-2022 | 01-26-2022 | Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 7,297,709 tablets | Class II | Terminated |
| D-0548-2022 | 01-26-2022 | APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 6,380,282 tablets | Class II | Terminated |
| D-0549-2022 | 01-26-2022 | Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 452,038 tablets | Class II | Terminated |
| D-0547-2022 | 01-26-2022 | Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 990,197 tablets | Class II | Terminated |
| D-0195-2024 | 01-26-2022 | Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10 Package NDCs: 54305-507-10; 2000058693 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 units | Class II | Terminated |
| D-0523-2022 | 01-26-2022 | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 33,758,436 tablets | Class II | Terminated |
| D-0527-2022 | 01-26-2022 | Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 917,304 tablets | Class II | Terminated |
| D-0555-2022 | 01-26-2022 | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 37,464,418 tablets | Class II | Terminated |
| D-0173-2024 | 01-26-2022 | CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01 Package NDCs: 0378-6231-01; 0378-6231-05; 0378-6232-01; 0378-6232-05; 0378-6233-01; 0378-6233-05 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0539-2022 | 01-26-2022 | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 3,349,387 tablets | Class II | Terminated |
| D-0541-2022 | 01-26-2022 | Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 3,050,308 tablets | Class II | Terminated |
| D-0538-2022 | 01-26-2022 | HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00 | CGMP Deviations | ULTRAtab Laboratories, Inc. / 50,585,623 tablets | Class II | Terminated |
| D-0174-2024 | 01-26-2022 | Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
| D-0201-2024 | 01-26-2022 | Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01 Package NDCs: 0093-1712-01; 0093-1712-10; 0093-1713-01; 0093-1713-10; 0093-1714-01; 0093-1714-10; 0093-1715-01; 0093-1716-01; 0093-1716-10; 0093-1721-01; 0093-1721-10; 0093-1718-01; 0093-1723-01; 0093-1720-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | Class II | Terminated |
