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-0179-2026 | 11-12-2025 | Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01 | Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis | Medical Products Laboratories, Inc. / 41,328 bottles | Class II | Ongoing |
| D-0219-2026 | 11-11-2025 | Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 Package NDCs: 43598-907-56; 43598-908-56; 43598-023-53; 43598-022-56 | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. | Dr. Reddy's Laboratories, Inc. / 4800 54-count bottles | Class III | Ongoing |
| D-0198-2026 | 11-07-2025 | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17. Package NDCs: 0591-2921-18; 0591-2921-02; 0591-3216-17; 0591-3216-30; 0591-3217-26; 0591-3217-30 | Defective Container - A defect in the side-seal which allows leakage of product. | Teva Pharmaceuticals USA, Inc / 15,944 cartons | Class III | Ongoing |
| D-0182-2026 | 11-06-2025 | Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale). Package NDCs: 63323-739-11; 63323-739-12 | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Fresenius Kabi USA, LLC / 2,199,850 vials | Class I | Ongoing |
| D-0227-2026 | 11-05-2025 | Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09. Package NDCs: 68180-351-08; 68180-351-06; 68180-351-09; 68180-351-03; 68180-351-01; 68180-352-11; 68180-352-01; 68180-352-03; 68180-352-06; 68180-352-09; 68180-352-02; 68180-352-05; 68180-353-11; 68180-353-01; 68180-353-03; 68180-353-02; 68180-353-06; 68180-353-09; 68180-353-05; 68180-978-01; 68180-978-02; 68180-978-03; 68180-986-04; 68180-986-02; 68180-986-01; 68180-986-03; 68180-992-04; 68180-992-01; 68180-992-02; 68180-992-03 | Defective container - seal not adhering to bottles | Lupin Pharmaceuticals Inc. / 52,128 bottles | Class II | Ongoing |
| D-0202-2026 | 10-31-2025 | Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04. Package NDCs: 67777-407-01; 67777-407-02; 67777-407-03; 67777-407-10; 67777-407-04; 67777-407-11; 67777-407-12; 67777-407-13 | cGMP deviations | Blossom Pharmaceuticals / 1560 containers | Class II | Ongoing |
| D-0207-2026 | 10-31-2025 | Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03. Package NDCs: 67777-407-01; 67777-407-02; 67777-407-03; 67777-407-10; 67777-407-04; 67777-407-11; 67777-407-12; 67777-407-13 | cGMP deviations | Blossom Pharmaceuticals / 7944 containers | Class II | Ongoing |
| D-0205-2026 | 10-31-2025 | WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05. Package NDCs: 67777-223-01; 67777-223-11; 67777-223-02; 67777-223-03; 67777-223-13; 67777-223-04; 67777-223-05; 67777-223-06 | cGMP deviations | Blossom Pharmaceuticals / 2592 bottles | Class II | Ongoing |
| D-0211-2026 | 10-31-2025 | Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55. Package NDCs: 69396-087-01; 69396-087-55 | cGMP deviations | Blossom Pharmaceuticals / 14700 bottles | Class II | Ongoing |
| D-0229-2026 | 10-31-2025 | Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5. Package NDCs: 50227-1030-5 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 12,033 cartons | Class II | Ongoing |
| D-0228-2026 | 10-31-2025 | 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16. Package NDCs: 66312-181-16; 66312-176-16 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 18,789 cartons- 50 cartridges /carton | Class II | Ongoing |
| D-0204-2026 | 10-31-2025 | Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016. | cGMP deviations | Blossom Pharmaceuticals / 8184 bottles | Class II | Ongoing |
| D-0212-2026 | 10-31-2025 | Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02. Package NDCs: 69396-086-02 | cGMP deviations | Blossom Pharmaceuticals / 33000 containers | Class II | Ongoing |
| D-0197-2026 | 10-31-2025 | Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96 Package NDCs: 69097-709-96; 69097-708-96; 69097-708-31 | Failed Stability Specifications: Observed OOS results: eg results for colour index | Cipla Limited / 4,438 10x1mL cartons | Class II | Ongoing |
| D-0206-2026 | 10-31-2025 | Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15. Package NDCs: 75834-170-01; 75834-170-02; 75834-170-15 | cGMP deviations | Blossom Pharmaceuticals / 912 containers | Class II | Ongoing |
| D-0209-2026 | 10-31-2025 | Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02. Package NDCs: 75834-170-01; 75834-170-02; 75834-170-15 | cGMP deviations | Blossom Pharmaceuticals / 7920 bottles | Class II | Ongoing |
| D-0208-2026 | 10-31-2025 | Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01. Package NDCs: 75834-170-01; 75834-170-02; 75834-170-15 | cGMP deviations | Blossom Pharmaceuticals / 13536 containers | Class II | Ongoing |
| D-0213-2026 | 10-31-2025 | Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04. Package NDCs: 67777-234-02; 67777-234-01; 67777-234-04; 67777-234-03 | cGMP deviations | Blossom Pharmaceuticals / 2400 containers | Class II | Ongoing |
| D-0234-2026 | 10-31-2025 | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10 Package NDCs: 0362-0101-10 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 1,636 cartons | Class II | Ongoing |
| D-0232-2026 | 10-31-2025 | Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51. Package NDCs: 66975-406-51 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / | Class II | Ongoing |
| D-0231-2026 | 10-31-2025 | darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5. Package NDCs: 66467-9760-5 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 5,520 Cartons | Class II | Ongoing |
| D-0201-2026 | 10-31-2025 | Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319. | cGMP deviations | Blossom Pharmaceuticals / 9600 containers | Class II | Ongoing |
| D-0203-2026 | 10-31-2025 | Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01. Package NDCs: 67777-402-01; 67777-402-02 | cGMP deviations | Blossom Pharmaceuticals / 18912 containers | Class II | Ongoing |
| D-0230-2026 | 10-31-2025 | 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16. Package NDCs: 66312-441-16 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 5,825 | Class II | Ongoing |
| D-0233-2026 | 10-31-2025 | Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05. Package NDCs: 0362-0753-05 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 40 cartons | Class II | Ongoing |
| D-0210-2026 | 10-31-2025 | Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01. Package NDCs: 69396-087-01; 69396-087-55 | cGMP deviations | Blossom Pharmaceuticals / 12150 bottles | Class II | Ongoing |
| D-0181-2026 | 10-29-2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26 | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq | Otsuka ICU Medical LLC / | Class I | Ongoing |
| D-0180-2026 | 10-29-2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26 | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq | Otsuka ICU Medical LLC / 21,696 50mL flexible containers | Class I | Ongoing |
| D-0149-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0144-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0148-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0150-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0344-2026 | 10-28-2025 | Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0 | Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren | Agebox / 665 bottles | Class II | Ongoing |
| D-0345-2026 | 10-28-2025 | Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027 | Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren | Agebox / N/A | Class II | Ongoing |
| D-0145-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0146-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0147-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0143-2026 | 10-27-2025 | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 Package NDCs: 0990-7730-36; 0990-7730-37; 0990-7983-61; 0990-7983-02; 0990-7983-03; 0990-7983-09; 0990-7983-55; 0990-7983-53; 0990-7984-37; 0990-7984-20; 0990-7984-13; 0990-7984-23; 0990-7984-36; 0990-7985-02; 0990-7985-03; 0990-7985-09 | Lack of Assurance of Sterility: Potential for flexible container leaks. | Otsuka ICU Medical LLC / 509,360 100 mL bags | Class II | Ongoing |
| D-0218-2026 | 10-24-2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13. Package NDCs: 76282-476-45; 76282-476-90; 76282-477-15; 76282-477-90; 76282-478-13; 76282-478-90 | Failed stability specifications: Out of specification for hardness test | Cipla USA, Inc. / N/A | Class II | Ongoing |
| D-0217-2026 | 10-24-2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98. Package NDCs: 69097-934-57; 69097-934-98; 69097-935-89; 69097-935-98; 69097-936-65; 69097-936-98 | Failed stability specifications: Out of specification for hardness test | Cipla USA, Inc. / 1180 boxes | Class II | Ongoing |
| D-0159-2026 | 10-23-2025 | Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06 Package NDCs: 68382-110-06; 68382-110-01 | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. | Zydus Pharmaceuticals (USA) Inc / 36,624 bottles | Class II | Ongoing |
| D-0154-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0152-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0153-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0097-2026 | 10-21-2025 | Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11 Package NDCs: 0003-7125-11 | Lack of Assurance of Sterility. | Bristol-Myers Squibb Company / 12,778 total vials | Class II | Ongoing |
| D-0121-2026 | 10-21-2025 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. Package NDCs: 50580-378-01; 50580-378-02; 50580-378-03; 50580-378-04; 50580-378-05; 50580-378-06; 50580-378-07; 50580-378-08; 50580-378-37 | Defective Container | Kenvue Brands LLC / 3,816 bottles | Class II | Ongoing |
| D-0158-2026 | 10-20-2025 | NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90 Package NDCs: 51407-267-90; 51407-268-90 | Failed Dissolution Specifications | Golden State Medical Supply Inc. / 24,869 bottles | Class II | Ongoing |
| D-0157-2026 | 10-20-2025 | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05 | Subpotent Drug | Imprimis NJOF, LLC / 67,091 bottles | Class III | Ongoing |
| D-0388-2026 | 10-20-2025 | SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. | ANTHONY TRINH, 123Herbals LLC / N/A | Class I | Ongoing |
| D-0155-2026 | 10-17-2025 | Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 Package NDCs: 55305-135-01; 55305-135-02; 55305-135-03 | Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. | Aero Healthcare / N/A | Class II | Ongoing |
| D-0102-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11 Package NDCs: 68084-996-11; 68084-996-01; 68084-997-11; 68084-997-01 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 1,818 cartons | Class II | Ongoing |
| D-0101-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11 Package NDCs: 68084-996-11; 68084-996-01; 68084-997-11; 68084-997-01 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 1,970 cartons | Class II | Ongoing |
| D-0103-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33 Package NDCs: 60687-572-33; 60687-572-32 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 3,410 cartons | Class II | Ongoing |
| D-0119-2026 | 10-15-2025 | Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02 | Lack of Assurance of Sterility | ProRx LLC / 2,805 vials | Class II | Ongoing |
| D-0114-2026 | 10-15-2025 | Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09 | Lack of Assurance of Sterility | ProRx LLC / 2,809 vials | Class II | Ongoing |
| D-0116-2026 | 10-15-2025 | Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08 | Lack of Assurance of Sterility | ProRx LLC / 8,310 vials | Class II | Ongoing |
| D-0115-2026 | 10-15-2025 | Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04 | Lack of Assurance of Sterility | ProRx LLC / 8,400 vials | Class II | Ongoing |
| D-0118-2026 | 10-15-2025 | Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06 | Lack of Assurance of Sterility | ProRx LLC / 2,649 vials | Class II | Ongoing |
| D-0120-2026 | 10-15-2025 | Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03 | Lack of Assurance of Sterility | ProRx LLC / 2,761 vials | Class II | Ongoing |
| D-0117-2026 | 10-15-2025 | Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09 | Lack of Assurance of Sterility | ProRx LLC / 11,119 vials | Class II | Ongoing |
| D-0130-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 18,124 pellets | Class II | Ongoing |
| D-0135-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 21,324 pellets | Class II | Ongoing |
| D-0123-2026 | 10-14-2025 | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 1,329pellets | Class II | Ongoing |
| D-0133-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 64,924 pellets | Class II | Ongoing |
| D-0124-2026 | 10-14-2025 | Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 829 pellets | Class II | Ongoing |
| D-0125-2026 | 10-14-2025 | Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 829 pellets | Class II | Ongoing |
| D-0129-2026 | 10-14-2025 | Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 14,329 pellets | Class II | Ongoing |
| D-0128-2026 | 10-14-2025 | Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 4,829 pellets | Class II | Ongoing |
| D-0127-2026 | 10-14-2025 | Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 4,929 pellets | Class II | Ongoing |
| D-0131-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 36,924 pellets | Class II | Ongoing |
| D-0132-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 43,424 Pellets | Class II | Ongoing |
| D-0137-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 264,664 pellets | Class II | Ongoing |
| D-0136-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 103,444 pellets | Class II | Ongoing |
| D-0126-2026 | 10-14-2025 | Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 529 pellets | Class II | Ongoing |
| D-0134-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 31,124 pellets | Class II | Ongoing |
| D-0151-2026 | 10-13-2025 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7. | Subpotent drug; Clavulanate Potassium component | Teva Pharmaceuticals USA, Inc / 4680 cartons | Class II | Ongoing |
| D-0096-2026 | 10-10-2025 | Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 Package NDCs: 62175-320-46; 62175-320-43; 62175-322-46; 62175-322-43 | Failed Dissolution Specifications | Lannett Company Inc. / 46,848 90-count bottles | Class II | Ongoing |
| D-0214-2026 | 10-10-2025 | Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B. Package NDCs: 67457-426-00; 67457-426-12 | Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. | Safecor Health, LLC / 800 1mL vials | Class II | Ongoing |
| D-0142-2026 | 10-10-2025 | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 2,035 cartons | Class III | Ongoing |
| D-0140-2026 | 10-10-2025 | Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 1,866 cartons | Class III | Ongoing |
| D-0113-2026 | 10-10-2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50 | Presence of Particulate Matter | QuVa Pharma, Inc. / 75,885 syringes | Class II | Ongoing |
| D-0194-2026 | 10-10-2025 | Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8 | CGMP Deviations | CA BOTANA International, Inc. / N/A | Class II | Ongoing |
| D-0193-2026 | 10-10-2025 | Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0 | CGMP Deviations | CA BOTANA International, Inc. / 3295 bottles | Class II | Ongoing |
| D-0190-2026 | 10-10-2025 | Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1 | CGMP Deviations | CA BOTANA International, Inc. / 1617 tubes | Class II | Ongoing |
| D-0156-2026 | 10-10-2025 | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30 Package NDCs: 62332-175-30; 62332-175-90; 62332-175-91; 62332-175-10; 62332-176-30; 62332-176-90; 62332-176-91; 62332-176-10; 2405006633 | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited / 4,884 30-count bottles | Class III | Ongoing |
| D-0196-2026 | 10-10-2025 | Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8 | CGMP Deviations | CA BOTANA International, Inc. / 4890 bottles | Class II | Ongoing |
| D-0186-2026 | 10-10-2025 | Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05 | CGMP Deviations | CA BOTANA International, Inc. / 470 tubes | Class II | Ongoing |
| D-0185-2026 | 10-10-2025 | Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05 | CGMP Deviations | CA BOTANA International, Inc. / 555 tubes | Class II | Ongoing |
| D-0188-2026 | 10-10-2025 | Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02 | CGMP Deviations | CA BOTANA International, Inc. / 810 tubes | Class II | Ongoing |
| D-0187-2026 | 10-10-2025 | Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02 | CGMP Deviations | CA BOTANA International, Inc. / 874 tubes | Class II | Ongoing |
| D-0195-2026 | 10-10-2025 | CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17 | CGMP Deviations | CA BOTANA International, Inc. / 4890 bottles | Class II | Ongoing |
| D-0099-2026 | 10-10-2025 | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01. | Lack of Assurance of Sterility. | Samsung Bioepis Co., Ltd. / 5,518 packs (11,036 Syringes) 2 syringes/carton) | Class II | Ongoing |
| D-0183-2026 | 10-10-2025 | Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 | CGMP Deviations | CA BOTANA International, Inc. / 1167 tubes | Class II | Ongoing |
| D-0191-2026 | 10-10-2025 | Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5 | CGMP Deviations | CA BOTANA International, Inc. / 1492 tubes | Class II | Ongoing |
| D-0192-2026 | 10-10-2025 | Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6 | CGMP Deviations | CA BOTANA International, Inc. / 2090 tubes | Class II | Ongoing |
| D-0184-2026 | 10-10-2025 | Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17 | CGMP Deviations | CA BOTANA International, Inc. / 1401 tubes | Class II | Ongoing |
| D-0189-2026 | 10-10-2025 | Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02 | CGMP Deviations | CA BOTANA International, Inc. / 805 tubes | Class II | Ongoing |
| D-0031-2026 | 10-10-2025 | Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). Package NDCs: 0904-6665-61; 0904-6666-61; 0904-6667-61; 55154-3363-0; 55154-7992-0; 55154-7993-0 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | The Harvard Drug Group LLC / | Class II | Ongoing |
| D-0030-2026 | 10-10-2025 | Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 Package NDCs: 0904-6665-61; 0904-6666-61; 0904-6667-61 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | The Harvard Drug Group LLC / | Class II | Ongoing |
| D-0139-2026 | 10-10-2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 6,655 cartons | Class III | Ongoing |
