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-1456-2020 | 06-18-2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Sweet Mint, 500mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Rd Suite 1, Saginaw, MI 48603 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 200 bottles | Class I | Completed |
| D-1364-2020 | 06-17-2020 | Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | Preferred Pharmaceuticals, Inc. / 144 bottles | Class II | Terminated |
| D-1392-2020 | 06-17-2020 | Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12 Package NDCs: 63323-739-11; 63323-739-12 | TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state. | HF Acquisition Co. LLC / N/A | Class III | Terminated |
| D-1362-2020 | 06-16-2020 | Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19. | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Glaxosmithkline Consumer Healthcare Holdings / 78,132 bottles | Class II | Terminated |
| D-1361-2020 | 06-16-2020 | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12. Package NDCs: 0031-8760-12; 5030031876 | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Glaxosmithkline Consumer Healthcare Holdings / 132,336 bottles | Class II | Terminated |
| D-1311-2020 | 06-16-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46 | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | SCA Pharmaceuticals / 333 bags | Class II | Terminated |
| D-1486-2020 | 06-13-2020 | Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA | Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate. | Yusef Manufacturing Laboratories, LLC / | Class II | Terminated |
| D-1370-2020 | 06-12-2020 | Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05 Package NDCs: 65862-844-01; 65862-844-05; 65862-844-10; 65862-844-78; 65862-845-01; 65862-845-05; 65862-845-10; 65862-845-78; 65862-846-01; 65862-846-05; 65862-846-10; 65862-846-78; 65862-847-01; 65862-847-05; 65862-847-10; 65862-847-78 | Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. | Aurobindo Pharma USA Inc. / 1440 bottles | Class II | Terminated |
| D-1357-2020 | 06-12-2020 | Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. | Beaming White Llc / N/A | Class II | Terminated |
| D-1359-2020 | 06-12-2020 | Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. | Beaming White Llc / N/A | Class II | Terminated |
| D-1360-2020 | 06-12-2020 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61 | CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels. | The Harvard Drug Group / 1,906 Cartons | Class II | Terminated |
| D-1358-2020 | 06-12-2020 | Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. | Beaming White Llc / N/A | Class II | Terminated |
| D-1334-2020 | 06-11-2020 | Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) Package NDCs: 68180-336-07; 68180-336-02; 68180-336-01; 68180-337-07; 68180-337-01; 68180-337-02 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 6,540 bottles | Class II | Terminated |
| D-1308-2020 | 06-11-2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01 Package NDCs: 0143-9702-01; 0143-9701-01 | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. | Hikma Pharmaceuticals USA Inc. / 82,426 vials | Class II | Terminated |
| D-1309-2020 | 06-11-2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01 Package NDCs: 0143-9583-01 | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. | Hikma Pharmaceuticals USA Inc. / 17,998 vials | Class II | Terminated |
| D-1339-2020 | 06-10-2020 | Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15 Package NDCs: 0316-0221-15; 0316-0221-30 | Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | Crown Laboratories / 35,931 tubes | Class II | Terminated |
| D-1338-2020 | 06-10-2020 | Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30 Package NDCs: 0316-0221-15; 0316-0221-30 | Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | Crown Laboratories / 62,274 tubes | Class II | Terminated |
| D-1341-2020 | 06-10-2020 | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30. Package NDCs: 62332-097-30; 62332-097-71; 62332-097-91; 62332-097-31; 62332-097-10; 62332-098-30; 62332-098-31; 62332-098-91; 62332-098-10; 62332-098-71; 62332-099-30; 62332-099-31; 62332-099-71; 62332-099-91; 62332-099-10; 62332-100-30; 62332-100-31; 62332-100-71; 62332-100-91; 62332-100-10; 62332-101-30; 62332-101-31; 62332-101-71; 62332-101-91; 62332-101-10; 62332-102-30; 62332-102-31; 62332-102-71; 62332-102-91; 62332-102-10; 1905003298 | Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. | Alembic Pharmaceuticals Limited / 19,153 bottles | Class II | Terminated |
| D-1372-2020 | 06-10-2020 | Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11 | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. | American Health Packaging / 265 cartons | Class III | Terminated |
| D-1363-2020 | 06-09-2020 | Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419. | Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin. | MasterPharm LLC / 300 capsules | Class I | Terminated |
| D-1340-2020 | 06-05-2020 | Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04 | Discoloration: Out of Specification (OOS) result for APHA Color Test. | Akorn, Inc. / 17,424 bottles | Class III | Terminated |
| D-1356-2020 | 06-05-2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01 Package NDCs: 49483-623-09; 49483-623-01; 49483-623-50; 49483-623-10; 49483-624-01; 49483-624-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited / 11279 bottles | Class II | Terminated |
| D-1333-2020 | 06-05-2020 | metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127 Package NDCs: 72789-009-30; 72789-009-60; 72789-009-90; 72789-009-93; 49483-0623-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | PD-Rx Pharmaceuticals, Inc. / 1969 bottles | Class II | Terminated |
| D-1307-2020 | 06-05-2020 | metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | PD-Rx Pharmaceuticals, Inc. / 3703 bottles | Class II | Terminated |
| D-1304-2020 | 06-04-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | AVKARE Inc. / 88,545 bottles | Class II | Terminated |
| D-1305-2020 | 06-04-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | AVKARE Inc. / 1,586,913 bottles | Class II | Terminated |
| D-1375-2020 | 06-04-2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01 Package NDCs: 70069-231-01; 70069-232-01; 70069-233-01 | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC / 22,788 bottles | Class III | Terminated |
| D-1373-2020 | 06-04-2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01 Package NDCs: 70069-231-01; 70069-232-01; 70069-233-01 | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC / 383,437 bottles | Class III | Terminated |
| D-1374-2020 | 06-04-2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01 Package NDCs: 70069-231-01; 70069-232-01; 70069-233-01 | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC / 48,852 bottles | Class III | Terminated |
| D-1540-2020 | 06-03-2020 | Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3 | Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. | Yusef Manufacturing Laboratories, LLC / 2,558 pieces | Class II | Terminated |
| D-1417-2020 | 06-03-2020 | Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1 | Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer. | WALKER EMULSIONS INC / N/A | Class II | Terminated |
| D-1416-2020 | 06-03-2020 | Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1 | Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer. | WALKER EMULSIONS INC / N/A | Class II | Terminated |
| D-1337-2020 | 06-03-2020 | Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097 | cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications. | A.P. Deauville, LLC / 82,800 bottles | Class II | Terminated |
| D-1331-2020 | 06-02-2020 | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Teva Pharmaceuticals USA / a) 92,793 bottles and b) 4,824 bottles | Class II | Terminated |
| D-1332-2020 | 06-02-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Teva Pharmaceuticals USA / a) 15,329 bottles and b) 137 bottles | Class II | Terminated |
| D-1411-2020 | 06-01-2020 | Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094 | Subpotent Drug: Product was found to be subpotent. Product also has high pH levels | WORLD EVENT PROMOTIONS, LLC / 14050 bottles | Class II | Terminated |
| D-1343-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / 192 | Class II | Ongoing |
| D-1393-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1353-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1354-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1351-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1350-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1348-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1352-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1345-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1349-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1347-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1344-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1306-2020 | 05-29-2020 | Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83 Package NDCs: 0049-0013-81; 0049-0013-83; 0049-0014-81; 0049-0014-83; 0049-0710-01; 0049-0710-10; 0049-3003-01; 0049-3003-10 | Presence of Particulate Matter: particulate matter identified after reconstitution. | Pfizer Inc. / 94320 units | Class II | Terminated |
| D-1325-2020 | 05-28-2020 | Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41 Package NDCs: 0135-0094-41; 0135-0094-42; 0135-0095-41; 0135-0574-01 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 1,631,700 bottles & 27,300 Twin-Pack botles | Class II | Terminated |
| D-1289-2020 | 05-28-2020 | Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478. Package NDCs: 42291-366-01; 42291-366-10; 42291-367-01; 42291-367-10; 42291-368-60; 42291-368-50; 42291-369-60; 42291-369-50 | Presence of Foreign Substance consistent with granules from desiccant packs used during storage | AVKARE Inc. / 4124 bottles | Class III | Terminated |
| D-1323-2020 | 05-28-2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41 Package NDCs: 0135-0094-41; 0135-0094-42; 0135-0095-41; 0135-0574-01 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 151,344 bottles | Class II | Terminated |
| D-1322-2020 | 05-28-2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42 Package NDCs: 0135-0094-41; 0135-0094-42; 0135-0095-41; 0135-0574-01 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 119,364 bottles | Class II | Terminated |
| D-1290-2020 | 05-28-2020 | Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03. 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 | Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. | Lupin Pharmaceuticals Inc. / 4,224 bottles | Class II | Terminated |
| D-1302-2020 | 05-28-2020 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07 | Subpotent drug - Product did not contain drug. | QuVa Pharma, Inc. / 648 bags | Class II | Terminated |
| D-1324-2020 | 05-28-2020 | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 629,796 bottles | Class II | Terminated |
| D-1303-2020 | 05-27-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels | Apotex Inc. / 305,963 bottles | Class II | Completed |
| D-1342-2020 | 05-27-2020 | Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12 | Failed Dissolution Specifications | Pfizer Inc. / 544400 packages | Class III | Terminated |
| D-1281-2020 | 05-26-2020 | Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97. | Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product. | Jubilant Cadista Pharmaceuticals, Inc. / 1,313,333 tablets | Class III | Terminated |
| D-1291-2020 | 05-26-2020 | Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01 Package NDCs: 29300-468-05; 29300-468-10; 29300-468-50; 29300-468-01; 29300-136-01; 29300-136-05; 29300-136-10; 29300-136-50; 29300-137-01; 29300-137-05; 29300-137-10; 29300-137-25; 29300-135-01; 29300-135-05; 29300-135-10; 29300-135-50 | Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container. | UNICHEM PHARMACEUTICALS USA INC / 190,992 bottles | Class III | Terminated |
| D-1314-2020 | 05-26-2020 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30 | Failed Impurities/ Degradation Specifications | Aurobindo Pharma USA Inc. / 13322 bottles | Class III | Terminated |
| D-1315-2020 | 05-26-2020 | Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30 | Failed Impurities/ Degradation Specifications | Aurobindo Pharma USA Inc. / 7547 bottles | Class III | Terminated |
| D-1288-2020 | 05-22-2020 | Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. Package NDCs: 0904-0430-95; 0904-0430-04; 0904-0430-06 | Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result. | The Harvard Drug Group / 16,443 cartons | Class II | Terminated |
| D-1285-2020 | 05-22-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Some bottles may contain mixed strengths of the product. | Teva Pharmaceuticals USA / 33,280 bottles | Class II | Terminated |
| D-1287-2020 | 05-22-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Some bottles may contain mixed strengths of the product. | Teva Pharmaceuticals USA / 84,209 bottles | Class II | Terminated |
| D-1298-2020 | 05-22-2020 | NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01. Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Superpotent Drug. | Acella Pharmaceuticals, LLC / 112,140 bottles | Class I | Terminated |
| D-1299-2020 | 05-22-2020 | NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01. Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Superpotent Drug. | Acella Pharmaceuticals, LLC / 29,304 bottles | Class I | Terminated |
| D-1300-2020 | 05-22-2020 | NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01. Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Superpotent Drug. | Acella Pharmaceuticals, LLC / 49,128 bottles | Class I | Terminated |
| D-1286-2020 | 05-22-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Some bottles may contain mixed strengths of the product. | Teva Pharmaceuticals USA / 41,348 bottles | Class II | Terminated |
| D-1293-2020 | 05-19-2020 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11 Package NDCs: 62584-693-11; 62584-693-21 | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life). | American Health Packaging / 15,755 cartons | Class II | Terminated |
| D-1277-2020 | 05-19-2020 | LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 4,960 boxes | Class II | Ongoing |
| D-1376-2020 | 05-19-2020 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01 | Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded | Flexion Therapeutics, Inc. / 792 kits | Class III | Terminated |
| D-1279-2020 | 05-19-2020 | Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 1,800 pouches | Class II | Ongoing |
| D-1278-2020 | 05-19-2020 | LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 54,000 boxes | Class II | Ongoing |
| D-1280-2020 | 05-19-2020 | Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 72,600 boxes | Class II | Ongoing |
| D-1284-2020 | 05-15-2020 | Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02 | Failed impurities/ degradation specifications: Out of specification for organic impurities. | TRIOVA PHARMACEUTICALS LLC / 210 grams | Class II | Terminated |
| D-1276-2020 | 05-15-2020 | Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 Package NDCs: 55289-866-02; 55289-866-04; 55289-866-06; 55289-866-07; 55289-866-10; 55289-866-20; 55289-866-28; 55289-866-30; 55289-866-50; 55289-866-60; 55289-866-71; 55289-866-74; 55289-866-85; 55289-866-86; 55289-866-87; 55289-866-90; 55289-866-93; 55289-866-98; 55289-866-01; 55289-866-82; 55289-866-95; 55289-866-14 | Failed dissolution specifications | PD-Rx Pharmaceuticals, Inc. / 14,030 bottles | Class II | Terminated |
| D-1310-2020 | 05-15-2020 | EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037. | Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations. | Eco Lips Inc / 68,400 tubes | Class II | Terminated |
| D-1272-2020 | 05-14-2020 | Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05. Package NDCs: 76282-405-30; 76282-405-90; 76282-405-01; 76282-405-05; 76282-406-30; 76282-406-90; 76282-406-01; 76282-406-05 | Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing. | InvaGen Pharmaceuticals, Inc. / 2,202 bottles | Class III | Terminated |
| D-1282-2020 | 05-13-2020 | Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25. | Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants. | West-Ward Columbus Inc / 3336 Bottles | Class III | Terminated |
| D-1274-2020 | 05-13-2020 | Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. Package NDCs: 0143-2112-50; 0143-2112-05; 0143-2112-20 | Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result. | West-Ward Columbus Inc / 68,376 bottles | Class II | Terminated |
| D-1317-2020 | 05-11-2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05 Package NDCs: 13668-268-30; 13668-268-01; 13668-268-10; 13668-268-31; 13668-268-05; 13668-271-01; 13668-271-10; 13668-271-49; 13668-271-05 | Failed Dissolution Specifications | Torrent Pharma Inc. / 6228 Bottles | Class II | Terminated |
| D-1326-2020 | 05-11-2020 | Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1328-2020 | 05-11-2020 | Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1330-2020 | 05-11-2020 | Sterile Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1329-2020 | 05-11-2020 | Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1327-2020 | 05-11-2020 | Sterile Curcumin, 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1270-2020 | 05-08-2020 | LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09 | Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide. | ICU Medical Inc / 93,648 flexible container | Class I | Terminated |
| D-1271-2020 | 05-05-2020 | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50 Package NDCs: 67457-187-50 | Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution. | Mylan Institutional LLC / 3,010 vials | Class II | Terminated |
| D-1585-2020 | 05-05-2020 | Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4 | Short Fill | Exela Pharma Sciences LLC / 23,775 vials | Class III | Terminated |
| D-1262-2020 | 04-24-2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61 Package NDCs: 0904-6734-61; 0904-6736-61; 0904-6737-61; 0904-6735-61 | Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing. | The Harvard Drug Group / 678 cartons | Class III | Terminated |
| D-1256-2020 | 04-24-2020 | Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10 Package NDCs: 43598-509-30; 43598-509-90; 43598-509-10; 43598-510-30; 43598-510-90; 43598-510-10 | Discoloration: product contains brown pellets | Dr. Reddy's Laboratories, Inc. / 1752 bottles | Class III | Terminated |
| D-1335-2020 | 04-23-2020 | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350 | Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac | QuVa Pharma, Inc. / 17,050 syringes | Class III | Terminated |
| D-1259-2020 | 04-21-2020 | Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0 Package NDCs: 54643-5646-1; 54643-5648-1; 54643-5651-1; 54643-5647-0; 54643-5653-0; 54643-5655-0 | Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins | Sandoz, Inc / 17,500 units | Class II | Terminated |
| D-1297-2020 | 04-20-2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 3,497,575 vials | Class II | Terminated |
| D-1266-2020 | 04-20-2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08 Package NDCs: 0573-0871-08; 0573-0871-11 | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card | Glaxosmithkline Consumer Healthcare Holdings / 288 packages | Class III | Terminated |
| D-1267-2020 | 04-20-2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08 Package NDCs: 0573-0872-08; 0573-0872-11 | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card | Glaxosmithkline Consumer Healthcare Holdings / 288 packages | Class III | Terminated |
| D-1268-2020 | 04-20-2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08 Package NDCs: 0573-0873-08; 0573-0873-11 | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card | Glaxosmithkline Consumer Healthcare Holdings / 360 packages | Class III | Terminated |
| D-1296-2020 | 04-20-2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 5,314,400 vials | Class I | Terminated |
| D-1250-2020 | 04-20-2020 | Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03 | Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles. | Lupin Pharmaceuticals Inc. / 11,808 bottles | Class II | Terminated |
