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-0701-2020 | 12-20-2019 | BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0689-2020 | 12-20-2019 | BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringe | Class II | Terminated |
| D-0750-2020 | 12-20-2019 | MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0676-2020 | 12-20-2019 | BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0712-2020 | 12-20-2019 | BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0738-2020 | 12-20-2019 | HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0667-2020 | 12-20-2019 | BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0675-2020 | 12-20-2019 | BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0704-2020 | 12-20-2019 | BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0723-2020 | 12-20-2019 | CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0758-2020 | 12-20-2019 | MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 3 syringes | Class II | Terminated |
| D-0755-2020 | 12-20-2019 | MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 3 syringes | Class II | Terminated |
| D-0710-2020 | 12-20-2019 | BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0756-2020 | 12-20-2019 | MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0764-2020 | 12-20-2019 | QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 190 vials | Class II | Terminated |
| D-0681-2020 | 12-20-2019 | BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0686-2020 | 12-20-2019 | BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0683-2020 | 12-20-2019 | BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 2 syringes | Class II | Terminated |
| D-0724-2020 | 12-20-2019 | CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Assurance Infusion / 1 syringe | Class II | Terminated |
| D-0634-2020 | 12-20-2019 | PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397. | Superpotent Drug: Salicylic acid content is above the firm's specification. | Island Kinetics, Inc. d.b.a. CoValence Laboratories / 2542 units | Class III | Terminated |
| D-0833-2020 | 12-20-2019 | Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1. Package NDCs: 51672-4130-6; 51672-4130-4; 51672-4130-1; 51672-4130-3; 51672-4130-0; 51672-4131-6; 51672-4131-4; 51672-4131-1; 51672-4131-3; 51672-4131-0; 51672-4132-6; 51672-4132-4; 51672-4132-1; 51672-4132-2; 51672-4132-3; 51672-4132-0; 51672-4133-6; 51672-4133-4; 51672-4133-1; 51672-4133-2; 51672-4133-3; 51672-4133-0 | Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. | Taro Pharmaceuticals U.S.A., Inc. / | Class I | Terminated |
| D-0816-2020 | 12-18-2019 | Squaric Acid 0.1% Topical Solution (Clinic) 30 mL | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0807-2020 | 12-18-2019 | Liothyronine (T3) 80 mcg SR cap | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 5 bottles | Class II | Terminated |
| D-0809-2020 | 12-18-2019 | Magic Bullet Supplement | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottles | Class II | Terminated |
| D-0803-2020 | 12-18-2019 | DHEA/Pregnenol One 10.25 MG Cap | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0815-2020 | 12-18-2019 | Sildenafil 80 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0811-2020 | 12-18-2019 | Progesterone 200 mg Troche | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0818-2020 | 12-18-2019 | Tadalafil 20 mg Troche | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 9 bottles | Class II | Terminated |
| D-0804-2020 | 12-18-2019 | Finasteride/Biotin 1 mg/50 mcg | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0805-2020 | 12-18-2019 | Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 2 jars | Class II | Terminated |
| D-0812-2020 | 12-18-2019 | Progesterone 50 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0814-2020 | 12-18-2019 | Sildenafil 200 mg Troche (Clinic) | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 1 bottle | Class II | Terminated |
| D-0813-2020 | 12-18-2019 | Progesterone E4M SR 100 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 3 bottles | Class II | Terminated |
| D-0820-2020 | 12-18-2019 | Testosterone Topical Cream 4% | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 3 bottles | Class II | Terminated |
| D-0819-2020 | 12-18-2019 | Tadalafil 6 mg Capsule | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 7 bottles | Class II | Terminated |
| D-0817-2020 | 12-18-2019 | T3/T4 SR 9 mcg/38 mcg capsule | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 2 bottles | Class II | Terminated |
| D-0806-2020 | 12-18-2019 | Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 12 jars | Class II | Terminated |
| D-0810-2020 | 12-18-2019 | Naltrexone 4.5 mg capsule | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 2 bottles | Class II | Terminated |
| D-0808-2020 | 12-18-2019 | Liothyronine (T3) 92.5 MCG | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. | MPRX, Inc. dba Medical Park Pharmacy / 4 bottles | Class II | Terminated |
| D-0640-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 217,956 bottles | Class II | Ongoing |
| D-0641-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 98,988 bottles | Class II | Ongoing |
| D-0639-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 208,668 bottles | Class II | Ongoing |
| D-0644-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 1,712,632 bottles | Class II | Ongoing |
| D-0642-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 1,309,536 bottles | Class II | Ongoing |
| D-0643-2020 | 12-17-2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20 | CGMP Deviations: Presence of NDMA impurity detected in product. | Glenmark Pharmaceuticals Inc., USA / 500,960 bottles | Class II | Ongoing |
| D-0656-2020 | 12-17-2019 | Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp / 5 boxes | Class I | Terminated |
| D-0654-2020 | 12-17-2019 | Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp / 8 boxes | Class I | Terminated |
| D-0655-2020 | 12-17-2019 | Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp / 7 boxes | Class I | Terminated |
| D-0657-2020 | 12-17-2019 | Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Motto International Corp / 1 box | Class I | Terminated |
| D-0864-2020 | 12-17-2019 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA. Package NDCs: 0641-6043-01; 0641-6043-25; 0641-6042-01; 0641-6042-25; 0641-6041-01; 0641-6041-25 | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Hikma Pharmaceuticals USA Inc. / 101,710 25 vials/shelf-pack | Class I | Terminated |
| D-0658-2020 | 12-17-2019 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA. Package NDCs: 0641-6043-01; 0641-6043-25; 0641-6042-01; 0641-6042-25; 0641-6041-01; 0641-6041-25 | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Hikma Pharmaceuticals USA Inc. / 25,817 shelf packs/25 vials per pack | Class II | Terminated |
| D-0839-2020 | 12-16-2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10. | Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product. | Akorn Inc / 16,078 bottles | Class II | Terminated |
| D-0625-2020 | 12-16-2019 | NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478. | Subpotent Drug | Pharmedium Services, LLC / 5820 bags | Class III | Terminated |
| D-0626-2020 | 12-16-2019 | NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478. | Subpotent Drug | Pharmedium Services, LLC / 864 bags | Class III | Terminated |
| D-0627-2020 | 12-16-2019 | NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478. | Subpotent Drug | Pharmedium Services, LLC / 5808 bags | Class III | Terminated |
| D-0635-2020 | 12-13-2019 | Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03. | Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity. | Lupin Pharmaceuticals Inc. / 2,130 bottles | Class III | Terminated |
| D-0632-2020 | 12-13-2019 | RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 Package NDCs: 62207-774-58; 62207-774-41; 62207-774-47; 62207-774-36; 62207-773-58; 62207-773-41; 62207-773-47; 62207-773-32; 62207-773-36 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Granules India Limited / 23,090,000 tablets | Class II | Ongoing |
| D-0844-2020 | 12-13-2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61 Package NDCs: 0904-6734-61; 0904-6736-61; 0904-6737-61; 0904-6735-61 | Failed Dissolution Specifications: High out of specification result observed at stability studies. | The Harvard Drug Group / 246 Cartons | Class III | Terminated |
| D-0628-2020 | 12-11-2019 | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248. | Subpotent Drug: Supplier indicated assay results did not meet specifications. | Spectrum Laboratory Products / 6.284 kg | Class II | Terminated |
| D-0798-2020 | 12-11-2019 | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00 | CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels. | RemedyRepack Inc. / 4,486 tablets | Class II | Terminated |
| D-0629-2020 | 12-10-2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA Package NDCs: 68180-246-06; 68180-249-06; 68180-249-09; 68180-249-02; 68180-247-06; 68180-247-09; 68180-248-06 | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Lupin Pharmaceuticals Inc. / 3,726 bottles | Class III | Terminated |
| D-0652-2020 | 12-09-2019 | Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38 | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. | Asclemed USA Inc. dba Enovachem Pharmaceuticals / 56.4 gm | Class II | Terminated |
| D-0651-2020 | 12-09-2019 | Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37 | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. | Asclemed USA Inc. dba Enovachem Pharmaceuticals / 42.12 gm | Class II | Terminated |
| D-0650-2020 | 12-09-2019 | Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36 | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results. | Asclemed USA Inc. dba Enovachem Pharmaceuticals / 8.52 gm | Class II | Terminated |
| D-0630-2020 | 12-06-2019 | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80 | Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count. | Lannett Company, Inc. / 16,668 bottles | Class I | Terminated |
| D-0854-2020 | 12-04-2019 | Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11 Package NDCs: 60687-266-11; 60687-266-21 | Failed Dissolution Specifications: Low out of specification results obtained during stability testing. | American Health Packaging / 973 cartons | Class II | Terminated |
| D-0576-2020 | 12-02-2019 | Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01. | Presence of Foreign Substance: Presence of a foreign object in a single tablet. | Jubilant Cadista Pharmaceuticals, Inc. / 1,824 bottles | Class II | Terminated |
| D-0617-2020 | 12-02-2019 | Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals | CGMP Deviations: Presence of NDMA impurity detected in product. | Preferred Pharmaceuticals, Inc / 316 bottles | Class II | Terminated |
| D-0789-2020 | 12-02-2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03. | Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. | AuroMedics Pharma LLC / 100,080 bottles | Class III | Terminated |
| D-0577-2020 | 11-27-2019 | 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10 Package NDCs: 0409-1775-40; 0409-1775-10 | Labeling: Incorrect or Missing Lot and/or expiration date. | Pfizer Inc. / 77,100 syringes | Class II | Terminated |
| D-0620-2020 | 11-26-2019 | Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09 | Presence of Foreign Substance: Foreign material found inside the vial (manufacturer). | SCA Pharmaceuticals, LLC / 1363 syringes | Class II | Terminated |
| D-0624-2020 | 11-25-2019 | Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 | Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes. | OraLabs, Incorporated / N/A | Class II | Terminated |
| D-0623-2020 | 11-25-2019 | VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771. | Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable | Apothecus Pharmaceutical Corp. / a) 34,417 cans b)142 cases 5,112 cans | Class III | Terminated |
| D-0574-2020 | 11-25-2019 | Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20. Package NDCs: 55150-203-10; 55150-204-20 | Discoloration: Product complaints of discoloration after reconstitution of vials. | AuroMedics Pharma LLC / 275,060 vials | Class II | Terminated |
| D-0622-2020 | 11-25-2019 | Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA | Failed Impurities/Degradation Specifications | Medisca, Inc. / 640,325 grams | Class II | Terminated |
| D-0615-2020 | 11-22-2019 | Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. Package NDCs: 53746-253-60; 53746-253-01; 53746-253-18; 53746-253-05; 53746-253-10; 53746-254-30; 53746-254-01; 53746-254-02 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. / N/A | Class II | Ongoing |
| D-0616-2020 | 11-22-2019 | Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. Package NDCs: 53746-253-60; 53746-253-01; 53746-253-18; 53746-253-05; 53746-253-10; 53746-254-30; 53746-254-01; 53746-254-02 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. / N/A | Class II | Ongoing |
| D-0612-2020 | 11-22-2019 | Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11). | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. / N/A | Class II | Ongoing |
| D-0613-2020 | 11-22-2019 | Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25). | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. / N/A | Class II | Ongoing |
| D-0614-2020 | 11-22-2019 | Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Amneal Pharmaceuticals, Inc. / N/A | Class II | Ongoing |
| D-0621-2020 | 11-21-2019 | EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20, Package NDCs: 65250-133-10; 65250-133-09; 65250-133-04; 65250-266-20; 65250-266-09; 65250-266-04 | Sub Potent Drug: Out of Specification (OOS) | Pacira Pharmaceuticals, Inc. / 910 20 mL vials | Class II | Terminated |
| D-0531-2020 | 11-21-2019 | Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01 | Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. | Preferred Pharmaceuticals, Inc / | Class II | Terminated |
| D-1003-2020 | 11-20-2019 | Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11 | CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. | American Health Packaging / 53,619 cartons | Class II | Terminated |
| D-0637-2020 | 11-20-2019 | Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05 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 | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. | AuroMedics Pharma LLC / N/A | Class I | Terminated |
| D-0636-2020 | 11-20-2019 | Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05 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 | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. | AuroMedics Pharma LLC / N/A | Class I | Terminated |
| D-0786-2020 | 11-20-2019 | SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912 | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs / Unknown | Class III | Terminated |
| D-0785-2020 | 11-20-2019 | SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912 | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs / Unknown | Class III | Terminated |
| D-0784-2020 | 11-20-2019 | SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912 | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs / Unknown | Class III | Terminated |
| D-0783-2020 | 11-20-2019 | SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912 | Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product. | Idelle Labs / Unknown | Class III | Terminated |
| D-0517-2020 | 11-19-2019 | 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29 Package NDCs: 0338-0047-24; 0338-0047-27; 0338-0047-29 | Lack of Assurance of Sterility: Product has the potential to leak. | Baxter Healthcare Corporation / 22336 bags | Class II | Terminated |
| D-0653-2020 | 11-19-2019 | Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99 | Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles.. | AuroMedics Pharma LLC / | Class II | Terminated |
| D-0618-2020 | 11-15-2019 | Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430 Package NDCs: 68462-608-94; 68462-608-27 | Defective delivery system; product is not foaming or is coming out as liquid. | Glenmark Pharmaceuticals Inc., USA / a) 34521 bottles; b) 16930 bottles | Class III | Terminated |
| D-0619-2020 | 11-15-2019 | Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-625-94; 68462-625-27 | Defective delivery system; product is not foaming or is coming out as liquid. | Glenmark Pharmaceuticals Inc., USA / a) 480 packs; b) 240 packs | Class III | Terminated |
| D-1367-2020 | 11-15-2019 | Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05 Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml. | Rising Pharmaceuticals, Inc. / N/A | Class III | Terminated |
| D-1049-2020 | 11-15-2019 | Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1 Package NDCs: 44911-0411-1 | Labeling mix-up - Indications on product label are incorrect. | Grato Holdings, Inc. / 659 bottles | Class III | Terminated |
| D-1368-2020 | 11-15-2019 | Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05 Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml. | Rising Pharmaceuticals, Inc. / 15,072 bottles | Class III | Terminated |
| D-0647-2020 | 11-15-2019 | MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13. | Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product. | Akorn, Inc. / 4,206 boxes | Class II | Terminated |
| D-0781-2020 | 11-14-2019 | Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062. | cGMP violations | Wisconsin Pharmacal Company, LLC / 44,373 cartons | Class II | Terminated |
| D-0525-2020 | 11-14-2019 | AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. / 104,797 bottles | Class II | Terminated |
| D-0524-2020 | 11-14-2019 | AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. / 631,138 bottles | Class II | Terminated |
