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-1120-2020 | 03-24-2020 | Detoxin-S, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1160-2020 | 03-24-2020 | Skin Lift Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1147-2020 | 03-24-2020 | Pain Away, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1171-2020 | 03-24-2020 | Voice Rescue, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1164-2020 | 03-24-2020 | Sugar Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1172-2020 | 03-24-2020 | Worm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1162-2020 | 03-24-2020 | Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1114-2020 | 03-24-2020 | Cellulite Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1130-2020 | 03-24-2020 | Hair Back Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1174-2020 | 03-24-2020 | Thyro-H, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1106-2020 | 03-24-2020 | Acne Cystic, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1140-2020 | 03-24-2020 | Lipidtrol, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1167-2020 | 03-24-2020 | Tution 130, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1112-2020 | 03-24-2020 | Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1143-2020 | 03-24-2020 | Max Slim, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1146-2020 | 03-24-2020 | New Life, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1113-2020 | 03-24-2020 | Blood Clot Purger, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1158-2020 | 03-24-2020 | Skin De-Tag, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1170-2020 | 03-24-2020 | Vitiligo Off Ointment, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1156-2020 | 03-24-2020 | Reman-AP, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1155-2020 | 03-24-2020 | Reman-8, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1149-2020 | 03-24-2020 | PC Shrinker, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1150-2020 | 03-24-2020 | Phlegm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1105-2020 | 03-24-2020 | Acupuncture, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1173-2020 | 03-24-2020 | BioMycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1109-2020 | 03-24-2020 | Age Stop Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1115-2020 | 03-24-2020 | De-Fibroidin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1133-2020 | 03-24-2020 | Herpes Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1117-2020 | 03-24-2020 | Dermatoxin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1154-2020 | 03-24-2020 | Reman-6, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1110-2020 | 03-24-2020 | Asma Stopper, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1131-2020 | 03-24-2020 | Hernia Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1107-2020 | 03-24-2020 | Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1122-2020 | 03-24-2020 | Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1125-2020 | 03-24-2020 | Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1161-2020 | 03-24-2020 | Skin Moist, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1129-2020 | 03-24-2020 | Hair Back Ex, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1153-2020 | 03-24-2020 | Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1148-2020 | 03-24-2020 | Pain Stopper, 500mg Capsules, 90-count bottle, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1119-2020 | 03-24-2020 | Detoxin Ex, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1111-2020 | 03-24-2020 | Asthma Chest Rub, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1169-2020 | 03-24-2020 | Vigo-XXX, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1159-2020 | 03-24-2020 | Skin Lift, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1166-2020 | 03-24-2020 | Thyro-Lo, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1128-2020 | 03-24-2020 | Fungo Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1123-2020 | 03-24-2020 | Fire Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1151-2020 | 03-24-2020 | Pimples Off Solution 60 ML, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1142-2020 | 03-24-2020 | Lupus Care, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1057-2020 | 03-23-2020 | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01 Package NDCs: 0378-2045-01; 0378-2046-01; 0378-2047-01 | Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. | Mylan Pharmaceuticals Inc. / 3,816 botlles | Class III | Terminated |
| D-1254-2020 | 03-23-2020 | Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01 Package NDCs: 23155-017-01; 23155-018-01 | Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. | Avet Pharmaceuticals, Inc. / 17,524 bottles | Class I | Terminated |
| D-1255-2020 | 03-23-2020 | Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01 Package NDCs: 23155-017-01; 23155-018-01 | Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. | Avet Pharmaceuticals, Inc. / 4,444 bottles | Class I | Terminated |
| D-1060-2020 | 03-19-2020 | Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16. Package NDCs: 0121-0810-02; 0121-0810-16; 0121-4810-05; 0121-4810-40; 0121-4810-00; 0121-4810-50 | SubPotent Drug: Low out-of-specification results for assay testing. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 7416 bottles | Class II | Terminated |
| D-1062-2020 | 03-19-2020 | DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30 | Failed Stability Specifications | Jubilant Draximage Inc / 473 kits of 30 vials | Class II | Terminated |
| D-0238-2021 | 03-19-2020 | Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178 | Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired. | Edge Pharma, LLC / 48 syringes | Class II | Terminated |
| D-0226-2021 | 03-19-2020 | Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505 | Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired. | Edge Pharma, LLC / 71 syringes | Class II | Terminated |
| D-1242-2020 | 03-19-2020 | Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144 | Microbial contamination of non-sterile products: positive test for yeast and bacteria. | Filltech USA, LLC / 4790 tottles; 20,403 tubes | Class II | Terminated |
| D-1241-2020 | 03-19-2020 | Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698 | Microbial contamination of non-sterile products: positive test for yeast and bacteria. | Filltech USA, LLC / 4919 tottles | Class II | Terminated |
| D-1233-2020 | 03-18-2020 | Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08 Package NDCs: 65862-245-08; 65862-245-05; 65862-246-08; 65862-246-05; 65862-247-08; 65862-247-05; 65862-315-30; 65862-315-60; 65862-315-05 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 8040 units | Class II | Terminated |
| D-1236-2020 | 03-18-2020 | Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01 Package NDCs: 13107-105-30; 13107-105-01; 13107-106-30; 13107-106-01 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 2101 units | Class II | Terminated |
| D-1232-2020 | 03-18-2020 | Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99 Package NDCs: 65862-198-01; 65862-198-05; 65862-198-99; 65862-198-10; 65862-198-90; 65862-198-18; 65862-198-27; 65862-199-01; 65862-199-05; 65862-199-99; 65862-199-10; 65862-199-30; 65862-199-60; 65862-199-90; 65862-199-18; 65862-199-27; 65862-200-01; 65862-200-05; 65862-200-10; 65862-200-90; 65862-200-27 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 26625 units | Class II | Terminated |
| D-1235-2020 | 03-18-2020 | Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34 Package NDCs: 13107-001-30; 13107-001-60; 13107-001-90; 13107-001-01; 13107-001-05; 13107-031-30; 13107-031-34; 13107-031-60; 13107-031-90; 13107-031-01; 13107-031-05; 13107-031-32; 13107-003-30; 13107-003-34; 13107-003-60; 13107-003-90; 13107-003-01; 13107-003-05; 13107-003-32; 13107-032-34; 13107-032-60; 13107-032-90; 13107-032-01; 13107-032-05; 13107-032-32 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 56208 units | Class II | Terminated |
| D-1231-2020 | 03-18-2020 | Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01 Package NDCs: 13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 57337 units | Class II | Terminated |
| D-1237-2020 | 03-18-2020 | Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01 Package NDCs: 13107-043-30; 13107-043-01; 13107-043-05; 13107-043-99; 13107-044-30; 13107-044-01; 13107-044-05; 13107-044-99; 13107-045-30; 13107-045-01; 13107-045-05; 13107-045-99; 13107-046-30; 13107-046-01; 13107-046-05; 13107-046-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 14707 units | Class II | Terminated |
| D-1229-2020 | 03-18-2020 | Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01 Package NDCs: 13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 14194 units | Class II | Terminated |
| D-1230-2020 | 03-18-2020 | Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99 Package NDCs: 13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 4332 units | Class II | Terminated |
| D-1234-2020 | 03-18-2020 | Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90 Package NDCs: 65862-050-30; 65862-050-45; 65862-050-90; 65862-050-01; 65862-050-00; 65862-050-99; 65862-050-26; 65862-051-30; 65862-051-45; 65862-051-90; 65862-051-01; 65862-051-00; 65862-051-99; 65862-051-26; 65862-052-30; 65862-052-45; 65862-052-90; 65862-052-01; 65862-052-00; 65862-052-99; 65862-052-26; 65862-053-30; 65862-053-45; 65862-053-90; 65862-053-01; 65862-053-00; 65862-053-99; 65862-053-22; 65862-054-30; 65862-054-45; 65862-054-90; 65862-054-00; 65862-054-99; 65862-054-39 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 26976 units | Class II | Terminated |
| D-1066-2020 | 03-16-2020 | Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95 Package NDCs: 0573-0169-17; 0573-0169-02; 0573-0169-19; 0573-0169-20; 0573-0169-40; 0573-0169-11; 0573-0169-89; 0573-0169-30; 0573-0169-31; 0573-0169-86; 0573-0169-51; 0573-0169-43; 0573-0169-49; 0573-0169-52; 0573-0169-08; 0573-0169-22; 0573-0169-13; 0573-0169-76; 0573-0169-16; 0573-0149-13; 0573-0149-04; 0573-0149-66; 0573-0149-91; 0573-1769-20; 0573-1769-80; 0573-1769-89; 0573-1769-14; 0573-1769-13; 0573-1769-09; 0573-1769-02; 0573-1769-87; 0573-1769-16; 0573-1769-31; 0573-1769-92; 0573-1769-95; 0057317698 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 446,628 bottles | Class II | Terminated |
| D-1090-2020 | 03-16-2020 | ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1500 units | Class II | Terminated |
| D-1087-2020 | 03-16-2020 | rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 2250 units | Class II | Terminated |
| D-1093-2020 | 03-16-2020 | fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1350 units | Class II | Terminated |
| D-1067-2020 | 03-16-2020 | Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.) Package NDCs: 0573-0191-20; 0573-0191-50; 0573-0191-22; 0573-0191-75; 0057301917; 0057301915 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 151,056 bottles | Class II | Terminated |
| D-1082-2020 | 03-16-2020 | nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 80 units | Class II | Terminated |
| D-1081-2020 | 03-16-2020 | ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1075 units | Class II | Terminated |
| D-1088-2020 | 03-16-2020 | ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 375 units | Class II | Terminated |
| D-1084-2020 | 03-16-2020 | HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1840 units | Class II | Terminated |
| D-1089-2020 | 03-16-2020 | fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 290 units | Class II | Terminated |
| D-1092-2020 | 03-16-2020 | fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 75 units | Class II | Terminated |
| D-1091-2020 | 03-16-2020 | ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 900 units | Class II | Terminated |
| D-1085-2020 | 03-16-2020 | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 210 units | Class II | Terminated |
| D-1086-2020 | 03-16-2020 | succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 2475 units | Class II | Terminated |
| D-1080-2020 | 03-16-2020 | Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501 | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction | Y-O Management LLC, dba Natural Remedy Store / 19156 packets estimated distributed | Class I | Terminated |
| D-1068-2020 | 03-16-2020 | Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 566 blister packs | Class II | Terminated |
| D-1072-2020 | 03-16-2020 | Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952 | Lack of Assurance of Sterility | The Medicine Shoppe Pharmacy / 4 bottles | Class II | Terminated |
| D-1069-2020 | 03-16-2020 | Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 4,104 bottles | Class II | Terminated |
| D-1094-2020 | 03-16-2020 | Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. Package NDCs: 43598-405-11; 43598-405-16 | Defective Container: Recall is due to breaking and shattering of ampules upon opening | Dr. Reddy's Laboratories, Inc. / 10943 cartons | Class I | Terminated |
| D-1083-2020 | 03-16-2020 | rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 4625 units | Class II | Terminated |
| D-1065-2020 | 03-16-2020 | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister Package NDCs: 0573-0196-01; 0573-0196-10; 0573-0196-20; 0573-0196-02; 0573-2161-03; 0057301961; 0057301962 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 471,024 blisters | Class II | Terminated |
| D-1073-2020 | 03-13-2020 | C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 2 bottles | Class II | Terminated |
| D-1074-2020 | 03-13-2020 | C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 1 bottle | Class II | Terminated |
| D-1076-2020 | 03-13-2020 | C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 2 bags | Class II | Terminated |
| D-1075-2020 | 03-13-2020 | *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 1 cassette | Class II | Terminated |
| D-1077-2020 | 03-13-2020 | *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 2 bottles | Class II | Terminated |
| D-1032-2020 | 03-13-2020 | Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. Package NDCs: 63304-614-20; 63304-614-05; 63304-614-01; 63304-614-13; 63304-615-05; 63304-615-11; 63304-615-01; 63304-616-20; 63304-616-05; 63304-616-01; 63304-616-13; 63304-616-50 | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. | Sun Pharmaceutical Industries, Inc. / 624 bottles | Class II | Terminated |
| D-1033-2020 | 03-13-2020 | Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50. Package NDCs: 63304-614-20; 63304-614-05; 63304-614-01; 63304-614-13; 63304-615-05; 63304-615-11; 63304-615-01; 63304-616-20; 63304-616-05; 63304-616-01; 63304-616-13; 63304-616-50 | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. | Sun Pharmaceutical Industries, Inc. / 172,320 bottles | Class II | Terminated |
| D-1058-2020 | 03-11-2020 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90 | CGMP Deviations: Presence of dark brown discoloration on edges of tablets | Jubilant Cadista Pharmaceuticals, Inc. / 89,376 90-count bottles | Class II | Terminated |
| D-1054-2020 | 03-10-2020 | Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy / 89 troches | Class II | Terminated |
| D-1053-2020 | 03-10-2020 | Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy / 403 troches | Class II | Terminated |
| D-1052-2020 | 03-10-2020 | Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy / 71 troches | Class II | Terminated |
| D-1047-2020 | 03-09-2020 | Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05 Package NDCs: 63304-828-90; 63304-828-05; 63304-827-90; 63304-827-05; 63304-829-90; 63304-829-05; 63304-830-90; 63304-830-05 | Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. | Sun Pharmaceutical Industries, Inc. / 1416 bottles | Class II | Terminated |
| D-1031-2020 | 03-09-2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01 | Presence of particulate matter. presence of metal particles. | Mylan Pharmaceuticals Inc. / 300 100-count bottles | Class II | Terminated |
