Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting recalls for Bromocriptine Mesylate, Bupropion, Carbidopa/Levodopa/Entacapone combination tablets, Chlorpromazine, Clomipramine, Desipramine, Duloxetine, Niacin Extended Release, compounded Semaglutide, Tirzepatide, and Retatrutide products, and Walgreens Saline Nasal Spray.
All of the recalls in this installment have been assigned a “Class II” level by the FDA (see below for definitions of types of recalls). These are supplier-level recalls and not directed at consumers. However, consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates.
How to Read This Report
This report is prepared using the most recent information posted in the FDA’s Enforcement Reports Database (for recalls), Warning Letters Database (for warning letters), and Drug Imports Alerts Database (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.
Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:
Recalls (Enforcement Reports Database)
The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”
While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.
- Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
- Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
- Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.
Warning Letters (Warning Letters Database)
Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
Drug Imports Alerts Database
FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.
Drug Recalls
Bromocriptine Mesylate Capsules (generic for Parlodel)
Company: Zydus Pharmaceuticals
Manufacturing Location: Zydus Lifesciences, Ahmedabad, India
Scope: 36,624 bottles (5 mg, 30-count)
Drug Purpose: Treats hyperprolactinemia, or high levels of the hormone prolactin, which can be caused by a benign pituitary tumor.
Recall Reason: Failed impurities and degradation tests
Recall Initiation Date: October 23, 2025
Link: FDA Enforcement Report
Bupropion Hydrochloride Extended-Release Tablets XL (generic for Wellbutrin)
Company: Graviti Pharmaceuticals Private Limited; distributed and packaged by Rising Pharma
Manufacturing Location: Sangareddy, Telangana, India
Scope: 46,512 bottles (300 mg, 30-count)
Drug Purpose: Antidepressant
Recall Reason: Failed tablet/capsule specifications, which means the tablet failed quality control tests.
Recall Initiation Date: September 24, 2025
Link: FDA Enforcement Report
Carbidopa, Levodopa, Entacapone (Combination) Tablets
Company: Rising Pharma Holdings, Inc.
Manufacturing Location: Suven Pharmaceuticals Limited, Pashamylaram, Telangana, India
Scope: 2,064 100-count bottles of 25 mg/100 mg/200 mg film-coated tablets
Drug Purpose: Treats Parkinson’s disease
Recall Reason: Product mix-up: A complaint indicated that sealed bottles labeled as Carbidopa/Levodopa/Entacapone 25 mg/100 mg/200 mg actually contained the higher-strength 37.5 mg/150 mg/200 mg tablets.
Recall Initiation Date: October 7, 2025
Link: FDA Enforcement Report
Chlorpromazine Hydrochloride Tablets (formerly branded as Thorazine)
Company: Major Pharmaceuticals
Manufacturing Location: Not specified
Scope: 2,064 blister packs of 25 mg, 50 Tablets per blister package
Drug Purpose: Antipsychotic that treats schizophrenia and other mood disorders
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: September 12, 2025
Link: FDA Enforcement Report
Clomipramine Hydrochloride Capsules (generic for Anafranil)
Company: Zydus Pharmaceuticals (manufactured for Northstar Rx)
Manufacturing Location: Zydus Lifesciences Ltd., Ahmedabad, India
Scope: 25mg, 50mg, and 75mg capsules; quantity not specified
Drug Purpose: Treats obsessive compulsive disorder (OCD)
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: October 22, 2025
Link: FDA Recall Announcement
Desipramine HCL Tablets (generic for Norpramin)
Company: Heritage Pharmaceuticals (now doing business as Avet Pharmaceuticals)
Manufacturing Location: USV Private Ltd., Daman, India
Scope: 33,663 bottles of strengths ranging from 10 mg to 150 mg (50 and 100-count)
Drug Purpose: Tricyclic antidepressant
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit; Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: October 6, 2025
Link: FDA Enforcement Report
Duloxetine Delayed-Release Capsules (generic for Cymbalta)
Company: Breckenridge Pharmaceutical, Inc.
Manufacturing Location: Towa Pharmaceutical Europe, Martorelles (Barcelona), Spain
Scope: 172,263 bottles of 60mg strength capsules (90-count and 1000-count)
Drug Purpose: Antidepressant
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: Initiated October 9, 2025
Link: FDA Enforcement Report
Niacin Extended-Release Tablets
Company: Lannett Company
Manufacturing Location: Not specified
Scope: 46,848 bottles of 1,000 mg Tablets (90-count)
Drug Purpose: Used as a lipid-lowering agent to manage cholesterol levels
Recall Reason: Failed dissolution specifications; may not dissolve effectively after storage
Recall Initiation Date: October 10, 2025
Link: FDA Enforcement Report
Compounded Semaglutide and Tirzepatide
Company: ProRx LLC (licensed compounding pharmacy)
Manufacturing Location: Exton, Pennsylvania
Scope: More than 36,000 multidose vials of semaglutide in various strengths; 2,761 3 mL multidose vials of tirzepatide; both distributed in Texas and Utah
Drug Purpose: Treats type 2 diabetes and obesity
Recall Reason: Lack of assurance of sterility
Essential Extras: Earlier this year, ProRx received a warning letter from the FDA after a facility inspection revealed multiple Current Good Manufacturing Practice (CGMP) violations.
Recall Initiation Date: October 15, 2025
Link: FDA Enforcement Report
Compounded Semaglutide, Semaglutide with B12, Tirzepatide, Retatrutide, and Other Injectables
Company: GenoGenix, LLC (licensed compounding pharmacy); some products labeled as manufactured for Synergy Wellness
Manufacturing Location: Boca Raton, FL
Scope: 10 mL vials of Tirzepatide 60 mg/10 mL for injection; 10 mL multi-dose vials of Semaglutide 20 mg/mL; Semaglutide with Vitamin B12 for injection (all strengths); 54 additional compounded sterile injectable products, including amino-acid blends, vitamin D-3, Lipo MIC + B12 Methylcobalamin, and other vitamin/“wellness” injections
Drug Purpose: Treats type 2 diabetes and obesity; vitamins used for a variety of health reasons
Recall Reason: Lack of assurance of sterility
Essential Extras: Retatrutide, included among the products, is an experimental Eli Lilly obesity drug still in clinical trials. FDA explicitly warns that Retatrutide cannot be legally compounded because it is not on the FDA’s compounding bulks list and has no approved formulation.
Recall Initiation Date: July 30, 2025 (FDA did not classify this recall until October 21, 2025)
Link: FDA Enforcement Report
Walgreens Saline Nasal Spray with Xylitol
Company: Medical Products Laboratories (distributed by Walgreens)
Manufacturing Location: Not specified
Scope: 41,328 bottles, 1.5 oz (45mL)
Drug Purpose: Nasal saline spray for congestion relief
Recall Reason: Microbial contamination with Pseudomonas lactis, a type of bacteria
Recall Initiation Date: November 12, 2025
Link: FDA Enforcement Report
