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-1211-2020 | 04-06-2020 | Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1207-2020 | 04-06-2020 | Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1179-2020 | 04-06-2020 | Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1238-2020 | 04-03-2020 | Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA | CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. / | Class II | Terminated |
| D-1079-2020 | 04-01-2020 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01 Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets. | Lupin Pharmaceuticals Inc. / 25,944 bottles | Class II | Terminated |
| D-1247-2020 | 03-31-2020 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 7957 30-count boxes | Class II | Terminated |
| D-1249-2020 | 03-31-2020 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 14,142 30-count boxes | Class II | Terminated |
| D-1248-2020 | 03-31-2020 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 5,614 30-count boxes | Class II | Terminated |
| D-1071-2020 | 03-30-2020 | Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01 | Failed Impurities/Degradation Specification: Presence of unknown impurity observed. | Par Pharmaceutical Inc. / 29,352 bottles | Class II | Terminated |
| D-1096-2020 | 03-26-2020 | MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1098-2020 | 03-26-2020 | Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1104-2020 | 03-26-2020 | Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level | Avet Pharmaceuticals, Inc. / a) 12,168; b) 17,196; c) 3,890 | Class II | Terminated |
| D-1103-2020 | 03-26-2020 | Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level | Avet Pharmaceuticals, Inc. / a) 2,904; b) 14,316; c) 1,368 bottles | Class II | Terminated |
| D-1095-2020 | 03-26-2020 | Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1097-2020 | 03-26-2020 | Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1099-2020 | 03-26-2020 | Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530 | Lack of Assurance of Sterility | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy / N/A | Class II | Terminated |
| D-1258-2020 | 03-25-2020 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02 | Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing. | Akorn Inc / 15,170 ampules | Class III | Terminated |
| D-1102-2020 | 03-25-2020 | LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / N/A | Class II | Ongoing |
| D-1101-2020 | 03-25-2020 | LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / N/A | Class II | Ongoing |
| D-1100-2020 | 03-25-2020 | LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / N/A | Class II | Ongoing |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-1157-2020 | 03-24-2020 | Skin Cleanser, 500mg Capsules, 90-count bottles2, 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-1138-2020 | 03-24-2020 | Herpes-P, 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-1152-2020 | 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-1139-2020 | 03-24-2020 | Immune-2100, 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-1121-2020 | 03-24-2020 | Dragon Pain 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-1118-2020 | 03-24-2020 | DeTensin 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-1163-2020 | 03-24-2020 | Stomach Cleanser, 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-1108-2020 | 03-24-2020 | Age Back, 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-1124-2020 | 03-24-2020 | Flare 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-1116-2020 | 03-24-2020 | Dermamycin, 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-1134-2020 | 03-24-2020 | Herpes Soap, 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-1132-2020 | 03-24-2020 | Herpes-G, 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-1141-2020 | 03-24-2020 | Lump Shrinker, 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-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-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-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-1137-2020 | 03-24-2020 | Herpes-G, 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-1165-2020 | 03-24-2020 | Sweat Oil, 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-1135-2020 | 03-24-2020 | Herpes V 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-1168-2020 | 03-24-2020 | Vertigo 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-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-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-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-1126-2020 | 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-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-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-1144-2020 | 03-24-2020 | Metabolic Booster. 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-1127-2020 | 03-24-2020 | Fungo 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-1136-2020 | 03-24-2020 | Herpes V 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-1145-2020 | 03-24-2020 | Nasal Ez, 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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
