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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| 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-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-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-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-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-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-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-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-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-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-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 Package NDCs: 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-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-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-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-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-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-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-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-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 Package NDCs: 23155-001-01; 23155-001-10; 23155-002-10; 23155-002-01; 23155-003-01; 23155-003-10; 23155-004-01; 23155-004-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 2 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-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-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-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-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-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-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-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-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-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-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 Package NDCs: 0456-0457-01; 0456-1045-01; 0456-0458-01; 0456-0458-11; 0456-0458-63; 0456-0459-01; 0456-0459-11; 0456-0459-63; 0456-0460-01; 0456-0461-01; 0456-0461-11; 0456-0461-63; 0456-0462-01; 0456-0463-01; 0456-0464-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE / 1 unit | 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-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-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-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-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-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-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-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-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-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-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 |
