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-0809-2018 | 04-24-2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 199 tablets in 20-count containers | Class II | Terminated |
| D-0819-2018 | 04-24-2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01 | cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure | Mylan Pharmaceuticals Inc. / 25,488 bottles | Class II | Terminated |
| D-0820-2018 | 04-24-2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01 | cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure | Mylan Pharmaceuticals Inc. / 12,924 bottles | Class II | Terminated |
| D-0808-2018 | 04-24-2018 | Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 5 28-count containers | Class II | Terminated |
| D-0807-2018 | 04-24-2018 | Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482 | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F). | Prescript Pharmaceuticals, Inc. / 24 473-ml bottles | Class II | Terminated |
| D-0715-2018 | 04-23-2018 | Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10 | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Mckesson Packaging Services / 7656 cartons | Class III | Terminated |
| D-0714-2018 | 04-23-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10 | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Mckesson Packaging Services / 4266 cartons | Class III | Terminated |
| D-0727-2018 | 04-23-2018 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01 Package NDCs: 55111-468-30; 55111-468-60; 55111-468-01; 55111-468-05; 55111-468-79; 55111-468-78; 55111-469-30; 55111-469-60; 55111-469-01; 55111-469-05; 55111-469-79; 55111-469-78 | Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets. | Dr. Reddy's Laboratories, Inc. / 8160 bottles | Class II | Terminated |
| D-0716-2018 | 04-23-2018 | Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10 | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Mckesson Packaging Services / 2966 cartons | Class III | Terminated |
| D-0826-2018 | 04-20-2018 | Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06. | Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. | Exela Pharma Sciences LLC / 5256 bottles | Class II | Terminated |
| D-0802-2018 | 04-19-2018 | Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05 Package NDCs: 53489-145-01; 53489-145-05; 53489-146-01; 53489-146-05 | Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets. | Sun Pharmaceutical Industries, Inc. / 1,908 500-count bottles | Class II | Terminated |
| D-0710-2018 | 04-17-2018 | Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45 | Failed Dissolution Specification: Low dissolution outside of specifications | Rhodes Pharmaceuticals, L.P. / 2454 bottles | Class III | Terminated |
| D-0288-2019 | 04-16-2018 | Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3. | Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug. | Epic Products, LLC / a) 106,329 cards; b) 109,725 bottles; c) 28,644 bottles | Class I | Terminated |
| D-0712-2018 | 04-13-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200 Package NDCs: 64980-329-20; 3649803292 | Subpotent Drug | Lyne Laboratories, Inc. / 17939 units | Class II | Terminated |
| D-0711-2018 | 04-13-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043 Package NDCs: 64980-331-04; 3649803310 | Subpotent Drug | Lyne Laboratories, Inc. / 12572 units | Class II | Terminated |
| D-0713-2018 | 04-13-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046 Package NDCs: 64980-330-04; 3649803300 | Subpotent Drug | Lyne Laboratories, Inc. / 23453 units | Class II | Terminated |
| D-0828-2018 | 04-13-2018 | OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10 Package NDCs: 0362-0101-10 | Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point. | Septodont Inc. / 8509 boxes | Class III | Terminated |
| D-0803-2018 | 04-13-2018 | Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA | Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%. | Boiron Inc. / 52,810 tubes | Class III | Terminated |
| D-0821-2018 | 04-12-2018 | Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128 | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | AMA Wholesale / unknown | Class I | Terminated |
| D-0702-2018 | 04-11-2018 | NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14. | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 600 syringes | Class II | Terminated |
| D-0699-2018 | 04-11-2018 | Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10 | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 4555 syringes | Class II | Terminated |
| D-0700-2018 | 04-11-2018 | Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10 | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 4192 syringes | Class II | Terminated |
| D-0701-2018 | 04-11-2018 | Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10 | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. | Premier Pharmacy Labs Inc / 3570 syringes | Class II | Terminated |
| D-0815-2018 | 04-10-2018 | Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. Package NDCs: 45567-0455-1; 45567-0455-2 | Failed Stability Specifications | Pharmalucence, Inc. / 157 units (5 count) and 464 units (30 count) | Class II | Terminated |
| D-0632-2018 | 04-10-2018 | Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 | cGMP deviations | Pharmedium Services, LLC / 72 bags | Class III | Terminated |
| D-0810-2018 | 04-10-2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Presence of Foreign Tablets/Capsules | Aidarex Pharmaceuticals LLC / 450 bottles | Class III | Terminated |
| D-0627-2018 | 04-09-2018 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for adhesive transfer. | Noven Pharmaceuticals, Inc. / 9016 boxes of 30 patch each | Class II | Terminated |
| D-0683-2018 | 04-09-2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01 Package NDCs: 54482-020-01; 54482-020-02; 54482-035-02 | Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. | LEADIANT BIOSCIENCES, INC / 3,398 bottles | Class III | Terminated |
| D-0631-2018 | 04-06-2018 | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05. | Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous). | Sandoz Incorporated / 11,680 bottles | Class III | Terminated |
| D-0719-2018 | 04-05-2018 | HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 1506 vials | Class II | Terminated |
| D-0725-2018 | 04-05-2018 | METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 4524 vials | Class II | Terminated |
| D-0721-2018 | 04-05-2018 | LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 1309 vials | Class II | Terminated |
| D-0720-2018 | 04-05-2018 | LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 3959 vials | Class II | Terminated |
| D-0717-2018 | 04-05-2018 | CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 745 vials | Class II | Terminated |
| D-0724-2018 | 04-05-2018 | LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 8099 vials | Class II | Terminated |
| D-0718-2018 | 04-05-2018 | ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 200 vials | Class II | Terminated |
| D-0723-2018 | 04-05-2018 | LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 1457 vials | Class II | Terminated |
| D-0722-2018 | 04-05-2018 | LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 3733 vials | Class II | Terminated |
| D-0726-2018 | 04-05-2018 | PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Presence of Particulate matter. Recall due to presence of unknown particulate matter. | Coastal Meds, LLC. / 635 vials | Class II | Terminated |
| D-0800-2018 | 04-03-2018 | Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0760-2018 | 04-03-2018 | Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0793-2018 | 04-03-2018 | Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0764-2018 | 04-03-2018 | Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0787-2018 | 04-03-2018 | Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0745-2018 | 04-03-2018 | Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0736-2018 | 04-03-2018 | Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0766-2018 | 04-03-2018 | Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0798-2018 | 04-03-2018 | OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0790-2018 | 04-03-2018 | Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0786-2018 | 04-03-2018 | Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0783-2018 | 04-03-2018 | Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0739-2018 | 04-03-2018 | Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0740-2018 | 04-03-2018 | Otezla 30 mg tablet NDC 59572-0631-06 30 days supply; | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0758-2018 | 04-03-2018 | Xolair 150 mg SDV NDC 50242-0040-62 28 days | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0774-2018 | 04-03-2018 | Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0781-2018 | 04-03-2018 | Temozolomide 250 mg NDC 43975-0257-05 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0796-2018 | 04-03-2018 | Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0784-2018 | 04-03-2018 | Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0749-2018 | 04-03-2018 | Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0788-2018 | 04-03-2018 | Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0735-2018 | 04-03-2018 | Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0773-2018 | 04-03-2018 | Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0789-2018 | 04-03-2018 | Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0769-2018 | 04-03-2018 | Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0738-2018 | 04-03-2018 | Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0767-2018 | 04-03-2018 | Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0737-2018 | 04-03-2018 | Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0751-2018 | 04-03-2018 | Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0761-2018 | 04-03-2018 | Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0768-2018 | 04-03-2018 | Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0792-2018 | 04-03-2018 | Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0791-2018 | 04-03-2018 | Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0752-2018 | 04-03-2018 | Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0771-2018 | 04-03-2018 | Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0741-2018 | 04-03-2018 | Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0799-2018 | 04-03-2018 | Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0756-2018 | 04-03-2018 | MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / N/A | Class II | Terminated |
| D-0794-2018 | 04-03-2018 | Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0765-2018 | 04-03-2018 | Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0785-2018 | 04-03-2018 | Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0744-2018 | 04-03-2018 | Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0780-2018 | 04-03-2018 | Temozolomide 20 mg NDC 43975-0253-05 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0755-2018 | 04-03-2018 | Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0770-2018 | 04-03-2018 | Promacta 50 mg tablet NDC 00078-0686-15 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0746-2018 | 04-03-2018 | Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply; | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0775-2018 | 04-03-2018 | Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0750-2018 | 04-03-2018 | Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0747-2018 | 04-03-2018 | Botox 100 Units Vial NDC 00023-1145-01 90 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0734-2018 | 04-03-2018 | Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only, | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0743-2018 | 04-03-2018 | Altera Handset NDC 83490-0678-05 56 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0754-2018 | 04-03-2018 | Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0782-2018 | 04-03-2018 | Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0753-2018 | 04-03-2018 | Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0795-2018 | 04-03-2018 | Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0757-2018 | 04-03-2018 | Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0776-2018 | 04-03-2018 | Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0742-2018 | 04-03-2018 | Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0762-2018 | 04-03-2018 | Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0777-2018 | 04-03-2018 | Ibrance 125 mg cap NDC 00069-0189-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0772-2018 | 04-03-2018 | Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
