Drug Recalls

2,051 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

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Showing 751–800 of 2,051

Drug Recall · October 8, 2025
Mohamed Hagar
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Class I
Drug Recall · October 7, 2025
Teva Pharmaceuticals USA, Inc
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II
Drug Recall · October 7, 2025
Rising Pharma Holding, Inc.
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II
Drug Recall · October 7, 2025
Teva Pharmaceuticals USA, Inc
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II
Drug Recall · October 7, 2025
Teva Pharmaceuticals USA, Inc
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II
Drug Recall · October 6, 2025
Heritage Pharmaceuticals Inc
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Drug Recall · October 6, 2025
Heritage Pharmaceuticals Inc
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Drug Recall · October 6, 2025
VIONA PHARMACEUTICALS INC
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-
Discoloration
Class II
Drug Recall · October 6, 2025
Heritage Pharmaceuticals Inc
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Drug Recall · October 6, 2025
Heritage Pharmaceuticals Inc
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bru
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Drug Recall · October 6, 2025
Heritage Pharmaceuticals Inc
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brun
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Drug Recall · October 6, 2025
Heritage Pharmaceuticals Inc
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II
Drug Recall · October 3, 2025
Advanced Pharmaceutical Technology, Inc.
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Class II
Drug Recall · October 1, 2025
Church & Dwight Co., Inc.
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II
Drug Recall · October 1, 2025
Aspiro Pharma Limited
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO
Presence of Particulate Matter: Particulate matter identified as glass
Class II
Drug Recall · September 29, 2025
Acella Pharmaceuticals, LLC
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II
Drug Recall · September 29, 2025
Acuity Specialty Products, Inc.
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case,
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II
Drug Recall · September 29, 2025
Medline Industries, LP
Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Driv
Subpotent Drug
Class II
Drug Recall · September 29, 2025
Acuity Specialty Products, Inc.
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Config
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II
Drug Recall · September 26, 2025
Dr. Reddy's Laboratories, Inc.
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton,
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II
Drug Recall · September 25, 2025
SV Labs Prescott Corporation
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II
Drug Recall · September 24, 2025
Zydus Pharmaceuticals (USA) Inc
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II
Drug Recall · September 24, 2025
Zydus Pharmaceuticals (USA) Inc
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-92
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II
Drug Recall · September 23, 2025
ACME UNITED CORPORATION
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015
Product Mix-up
Class II
Drug Recall · September 23, 2025
Park Avenue Compounding
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II
Drug Recall · September 22, 2025
RC Outsourcing, LLC
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
Lack of assurance of sterility.
Class II
Drug Recall · September 19, 2025
Ascend Laboratories, LLC
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. Ind
Failed Dissolution Specifications
Class II
Drug Recall · September 19, 2025
Ascend Laboratories, LLC
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, D
Failed Dissolution Specifications
Class II
Drug Recall · September 19, 2025
Ascend Laboratories, LLC
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laborat
Failed Dissolution Specifications
Class II
Drug Recall · September 19, 2025
Ascend Laboratories, LLC
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories,
Failed Dissolution Specifications
Class II
Drug Recall · September 17, 2025
Glenmark Pharmaceuticals Inc., USA
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
CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II
Drug Recall · September 17, 2025
Park Avenue Compounding
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.
CGMP Deviations
Class II
Drug Recall · September 16, 2025
ACCORD HEALTHCARE, INC.
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
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II
Drug Recall · September 16, 2025
IntegraDose Compounding Services LLC
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
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class I
Drug Recall · September 15, 2025
Amerisource Health Services LLC
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
Failed Dissolution Specifications.
Class II
Drug Recall · September 15, 2025
Graviti Pharmaceuticals Private Limited
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
Failed Tablet/Capsule Specifications
Class II
Drug Recall · September 12, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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,
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Drug Recall · September 12, 2025
JB Chemicals and Pharmaceuticals Ltd
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
Tablet/Capsules Imprinted with Wrong ID
Class III
Drug Recall · September 12, 2025
Private Label Skin Care Inc.
edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II
Drug Recall · September 12, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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,
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Drug Recall · September 12, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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,
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Drug Recall · September 12, 2025
Private Label Skin Care Inc.
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II
Drug Recall · September 12, 2025
JB Chemicals and Pharmaceuticals Ltd
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
Tablet/Capsules Imprinted with Wrong ID
Class III
Drug Recall · September 12, 2025
Letco Medical LLC
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Labeling: Not Elsewhere Classified
Class III
Drug Recall · September 12, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Drug Recall · September 12, 2025
Private Label Skin Care Inc.
ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II
Drug Recall · September 12, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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,
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II
Drug Recall · September 12, 2025
Private Label Skin Care Inc.
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II
Drug Recall · September 12, 2025
Private Label Skin Care Inc.
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.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II
Drug Recall · September 12, 2025
Private Label Skin Care Inc.
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II