Drugs Recalls

FDA Drug Class II Ongoing

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., US

September 17, 2025 Glenmark Pharmaceuticals Inc., USA 13824 tubes units

FDA Drug Class II Ongoing

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.

September 17, 2025 Park Avenue Compounding 858 syringes units

FDA Drug Class I Ongoing

Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1

September 16, 2025 IntegraDose Compounding Services LLC 853/500 mL bags units

FDA Drug Class II Ongoing

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp

September 16, 2025 Accord Healthcare, Inc. 54,432 bottles units

FDA Drug Class II Ongoing

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC

September 15, 2025 Graviti Pharmaceuticals Private Limited 46,512/30 count bottles units

FDA Drug Class II Ongoing

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC

September 15, 2025 Amerisource Health Services LLC 360 cartons units

FDA Drug Class II Ongoing

edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.

September 12, 2025 Private Label Skin Care Inc. N/A units

FDA Drug Class II Ongoing

ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210

September 12, 2025 Private Label Skin Care Inc. 125 units

FDA Drug Class III Ongoing

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by

September 12, 2025 JB Chemicals and Pharmaceuticals Ltd 9936 bottles units

FDA Drug Class III Ongoing

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

September 12, 2025 Letco Medical LLC 173 500 ml bottles units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 1394 blister packs units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 506 blister packs units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 1256 blister packs units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UP

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2064 blister packs units

FDA Drug Class II Ongoing

mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210

September 12, 2025 Private Label Skin Care Inc. N/A units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 866 blister packs units

FDA Drug Class II Ongoing

Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825.

September 12, 2025 Private Label Skin Care Inc. N/A units

FDA Drug Class II Ongoing

Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211

September 12, 2025 Private Label Skin Care Inc. N/A units

FDA Drug Class III Ongoing

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by

September 12, 2025 JB Chemicals and Pharmaceuticals Ltd 13,440 bottles units

FDA Drug Class II Ongoing

Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com

September 12, 2025 Private Label Skin Care Inc. N/A units

FDA Drug Class II Ongoing

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Ap

September 5, 2025 Apotex Corp. 151,034 bottles units

FDA Drug Class II Ongoing

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 6

September 5, 2025 Apotex Corp. 493,468 bottles units

FDA Drug Class II Ongoing

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Prod

September 5, 2025 Sandoz, Inc 6 vials units

FDA Drug Class III Ongoing

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

September 5, 2025 Endo USA, Inc. 1,041 cartons units

FDA Drug Class II Ongoing

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

September 4, 2025 Zydus Pharmaceuticals USA Inc 4440 bottles units

FDA Drug Class II Ongoing