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-0981-2022 | 05-17-2022 | Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7 | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-0980-2022 | 05-17-2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9 | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0976-2022 | 05-17-2022 | AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0979-2022 | 05-17-2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6 | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0978-2022 | 05-17-2022 | AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0975-2022 | 05-17-2022 | Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-0977-2022 | 05-17-2022 | AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0888-2022 | 05-13-2022 | Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90 | CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Direct Rx / 16 bottles | Class II | Terminated |
| D-0896-2022 | 05-13-2022 | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13. | Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026. | GlaxoSmithKline LLC / 328 bottles | Class III | Terminated |
| D-1127-2022 | 05-13-2022 | Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C, 30C, 200C, 14X, 15X, 16X, 20X, 288X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 1,047 glass amber bottles | Class II | Terminated |
| D-1137-2022 | 05-13-2022 | Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 5 glass amber bottles | Class II | Terminated |
| D-1141-2022 | 05-13-2022 | Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 2 glass amber bottles | Class II | Terminated |
| D-1128-2022 | 05-13-2022 | Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 134 glass amber bottles | Class II | Terminated |
| D-1131-2022 | 05-13-2022 | Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 6,406 glass amber bottles | Class II | Terminated |
| D-1125-2022 | 05-13-2022 | Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 219 glass amber bottles | Class II | Terminated |
| D-1135-2022 | 05-13-2022 | Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 109 glass amber bottles | Class II | Terminated |
| D-1136-2022 | 05-13-2022 | Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 6,782 glass amber bottles | Class II | Terminated |
| D-1140-2022 | 05-13-2022 | Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 4 glass amber bottles | Class II | Terminated |
| D-1129-2022 | 05-13-2022 | Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 206 glass amber bottles | Class II | Terminated |
| D-1133-2022 | 05-13-2022 | Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 72 glass amber bottles | Class II | Terminated |
| D-1138-2022 | 05-13-2022 | Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 15 glass amber bottles | Class II | Terminated |
| D-1132-2022 | 05-13-2022 | Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 49 glass amber bottles | Class II | Terminated |
| D-1139-2022 | 05-13-2022 | Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 15 glass amber bottles | Class II | Terminated |
| D-1134-2022 | 05-13-2022 | Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 375 glass amber bottles | Class II | Terminated |
| D-1126-2022 | 05-13-2022 | Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 5 glass amber bottles | Class II | Terminated |
| D-1130-2022 | 05-13-2022 | Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411, | cGMP deviations | Washington Homeopathic Products, Inc. / 7 glass amber bottles | Class II | Terminated |
| D-1142-2022 | 05-11-2022 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901. | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | A.P. Nonweiler / 833 gallons | Class II | Ongoing |
| D-0893-2022 | 05-11-2022 | Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 Package NDCs: 72189-290-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx / 11 bottles | Class II | Terminated |
| D-0894-2022 | 05-11-2022 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 Package NDCs: 72189-297-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx / 6 bottles | Class II | Terminated |
| D-0895-2022 | 05-11-2022 | Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 Package NDCs: 72189-289-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx / 11 bottles | Class II | Terminated |
| D-0992-2022 | 05-11-2022 | Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60. | Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing. | Teva Pharmaceuticals USA Inc / 4224 cartons | Class I | Terminated |
| D-1148-2022 | 05-10-2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668 | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. | AMS Packaging Inc / unknown | Class II | Ongoing |
| D-0982-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936. Package NDCs: 0078-0911-05; 0078-0911-12; 0078-0911-95; 0078-0911-94 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 1,187,092 vials | Class III | Terminated |
| D-0984-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936. Package NDCs: 0078-0911-05; 0078-0911-12; 0078-0911-95; 0078-0911-94 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 279,179 vials | Class III | Terminated |
| D-0983-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 1,253,862 vials | Class III | Terminated |
| D-0985-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 279,179 vials | Class III | Terminated |
| D-0936-2022 | 05-09-2022 | Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 12800 vials | Class II | Completed |
| D-0926-2022 | 05-09-2022 | Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2441 vials | Class II | Completed |
| D-0930-2022 | 05-09-2022 | Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1195 vials | Class II | Completed |
| D-0900-2022 | 05-09-2022 | SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 75 vials | Class II | Completed |
| D-0931-2022 | 05-09-2022 | Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 310 vials | Class II | Completed |
| D-0918-2022 | 05-09-2022 | Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0079-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 7420 vials | Class II | Completed |
| D-0944-2022 | 05-09-2022 | PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 421 vials | Class II | Completed |
| D-0943-2022 | 05-09-2022 | Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 911 vials | Class II | Completed |
| D-0898-2022 | 05-09-2022 | RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 482 vials | Class II | Completed |
| D-0907-2022 | 05-09-2022 | Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 480 vials | Class II | Completed |
| D-0939-2022 | 05-09-2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0083-00. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 8982 vials | Class II | Completed |
| D-0906-2022 | 05-09-2022 | Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 943 vials | Class II | Completed |
| D-0897-2022 | 05-09-2022 | QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 914 vials | Class II | Completed |
| D-0908-2022 | 05-09-2022 | Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 588 vials | Class II | Completed |
| D-0942-2022 | 05-09-2022 | Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 8664 vials | Class II | Completed |
| D-0941-2022 | 05-09-2022 | Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 6113 vials | Class II | Completed |
| D-0933-2022 | 05-09-2022 | Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0047-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 4843 vials | Class II | Completed |
| D-0929-2022 | 05-09-2022 | Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 205 vials | Class II | Completed |
| D-0924-2022 | 05-09-2022 | Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0070-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1296 vials | Class II | Completed |
| D-0913-2022 | 05-09-2022 | Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2260 vials | Class II | Completed |
| D-0946-2022 | 05-09-2022 | Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0066-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1306 vials | Class II | Completed |
| D-0903-2022 | 05-09-2022 | Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 42,722 vials | Class II | Completed |
| D-0949-2022 | 05-09-2022 | Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 7761 vials | Class II | Completed |
| D-0934-2022 | 05-09-2022 | Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0048-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1571 vials | Class II | Completed |
| D-0928-2022 | 05-09-2022 | Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 72 vials | Class II | Completed |
| D-0940-2022 | 05-09-2022 | NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 606 vials | Class II | Completed |
| D-0905-2022 | 05-09-2022 | Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0074-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2333 vials | Class II | Completed |
| D-0909-2022 | 05-09-2022 | T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3312 vials | Class II | Completed |
| D-0925-2022 | 05-09-2022 | FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700 Olympia Pharmaceuticals, Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0006-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1159 vials | Class II | Completed |
| D-0911-2022 | 05-09-2022 | Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2198 vials | Class II | Completed |
| D-0904-2022 | 05-09-2022 | Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1466 vials | Class II | Completed |
| D-0917-2022 | 05-09-2022 | Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3286 vials | Class II | Completed |
| D-0910-2022 | 05-09-2022 | T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3185 vials | Class II | Completed |
| D-0935-2022 | 05-09-2022 | Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0072-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1597 vials | Class II | Completed |
| D-0899-2022 | 05-09-2022 | RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1710 vials | Class II | Completed |
| D-0902-2022 | 05-09-2022 | Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 4459 vials | Class II | Completed |
| D-0922-2022 | 05-09-2022 | Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0115-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1282 vials | Class II | Completed |
| D-0927-2022 | 05-09-2022 | Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1703 vials | Class II | Completed |
| D-0921-2022 | 05-09-2022 | Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0064-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 5443 vials | Class II | Completed |
| D-0912-2022 | 05-09-2022 | Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 33 vials | Class II | Completed |
| D-0932-2022 | 05-09-2022 | Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3762 vials | Class II | Completed |
| D-0915-2022 | 05-09-2022 | Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0075-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3083 vials | Class II | Completed |
| D-0938-2022 | 05-09-2022 | Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0088-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 13679 vials | Class II | Completed |
| D-0947-2022 | 05-09-2022 | QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 619 vials | Class II | Completed |
| D-0914-2022 | 05-09-2022 | Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0058-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 520 vials | Class II | Completed |
| D-0920-2022 | 05-09-2022 | Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1287 vials | Class II | Completed |
| D-0948-2022 | 05-09-2022 | QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0019-10. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 414 vials | Class II | Completed |
| D-0901-2022 | 05-09-2022 | SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 874 vials | Class II | Completed |
| D-0916-2022 | 05-09-2022 | Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1291 vials | Class II | Completed |
| D-0919-2022 | 05-09-2022 | AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 528 vials | Class II | Completed |
| D-0937-2022 | 05-09-2022 | MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 5334 vials | Class II | Completed |
| D-0945-2022 | 05-09-2022 | Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 9102 vials | Class II | Completed |
| D-0923-2022 | 05-09-2022 | Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0066-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1306 vials | Class II | Completed |
| D-1143-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 79339 syringes | Class II | Terminated |
| D-1146-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 180813 syringes | Class II | Terminated |
| D-1145-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40. Package NDCs: 62756-091-40 | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 4625 syringes | Class II | Terminated |
| D-1144-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 57997 syringes | Class II | Terminated |
| D-1147-2022 | 05-06-2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton. | Lack of assurance of sterility | SUN PHARMACEUTICAL INDUSTRIES INC / 26892 vials | Class II | Terminated |
| D-0889-2022 | 05-06-2022 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: customer complaints exceeded respective action limits. | Noven Pharmaceuticals Inc / 274, 110 patches | Class II | Ongoing |
| D-0971-2022 | 05-05-2022 | Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90 Package NDCs: 72189-012-90; 72189-098-90; 72189-129-90; 72189-129-30; 72189-139-30; 72189-139-90; 72189-167-30; 72189-167-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Direct Rx / 81 bottles | Class II | Terminated |
| D-0970-2022 | 05-05-2022 | Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800 9 | Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients. | Vi-Jon, LLC / 75,064 bottles | Class II | Terminated |
| D-0885-2022 | 05-04-2022 | Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | RemedyRepack Inc. / 22 bottles/90 count each | Class II | Terminated |
| D-0891-2022 | 05-03-2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Preferred Pharmaceuticals, Inc. / 31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E). | Class II | Terminated |
| D-0892-2022 | 05-03-2022 | Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Preferred Pharmaceuticals, Inc. / 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q). | Class II | Terminated |
