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 Budesonide, Cinacalcet, Clomipramine, Duloxetine, Gabapentin, Levothyroxine, Lisdexamfetamine, Omeprazole, Rizatriptan, and Sucralfate. 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). With the exception of Sucralfate, all of these are supplier-level recalls rather than consumer-directed ones.
However, consumers may wish to check the 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
Budesonide Ampoules (generic for Pulmicort)
Company: Cipla USA
Manufacturing Location: Pithampur, India
Scope: 13,680 ampoules (0.5mg/2ml)
Drug Description: Asthma treatment administered with a jet nebulizer
Recall Reason: Lack of assurance of sterility; some ampoules reported as leaky and/or empty
Recall Initiation Date: June 30, 2025
Link: FDA Enforcement Report
Cinacalcet Tablets (generic for Sensipar)
Company: Strides Pharma
Manufacturing Location: Puducherry, India
Scope: 6,672 bottles of 30-count tablets (90 mg)
Drug Description: Treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis
Recall Reason: Failed dissolution specifications; the drug may not be absorbed sufficiently to be effective.
Recall Initiation Date: July 9, 2025
Link: FDA Enforcement Report
Clomipramine Hydrochloride Capsules (generic for Anafranil)
Company: Lupin Pharmaceuticals Inc.
Manufacturing Location: Not specified
Scope: 2,724 bottles of 100-count capsules (25 mg)
Drug Description: Tricyclic antidepressant used to treat obsessive-compulsive disorder (OCD)
Recall Reason: Failed degradation product test near the product expiration date; this could affect the shelf-life of the product.
Recall Initiation Date: June 27, 2025
Link: FDA Enforcement Report
Duloxetine Delayed Release Tablets (generic for Cymbalta)
Company: Breckenridge
Manufacturing Location: Barcelona, Spain (by Towa Pharmaceuticals)
Scope: 12,242 30-count bottles (40 mg)
Drug Description: Treats depression
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: July 30, 2025
Essential Extras: Breckenridge issued a larger recall, for over 343,000 bottles, for other lots and strengths of this drug in April 2025.
Link: FDA Enforcement Report
Gabapentin Capsules (generic for Neurontin)
Company: The Harvard Drug Group’s Major Pharmaceuticals
Manufacturing Location: Not disclosed
Scope: 23,232 cartons (100 mg capsules) and 3,527 bags (100mg capsules)
Drug Description: Used to prevent and control seizures; also to relieve nerve pain and nerve pain following shingles.
Recall Reason: Defective blister packaging that may be inadequately sealed
Recall Initiation Date: June 27, 2025
Link: FDA Enforcement Report
Levothyroxine Sodium Tablets (generic for Synthroid)
Company: Accord Healthcare
Manufacturing Location: India
Scope: More than 160,000 bottles across several lots and formulations (25 mcg to 175 mcg)
Drug Description: Treats hypothyroidism
Recall Reason: Subpotent tablets with assay results below the approved potency specification
Recall Initiation Date: June 20, 2025
Link: FDA Enforcement Report
Lisdexamfetamine Dimesylate Capsules (generic for Vyvanse)
Company: Sun Pharmaceuticals (manufactured by OHM Laboratories)
Manufacturing Location: New Brunswick, NJ
Scope: 5,488 bottles of 100-count capsules (60 mg)
Drug Description: Stimulant treatment for ADHD in adults and children
Recall Reason: Failed dissolution specifications during 9-month long-term stability testing; product may not dissolve as intended after storage, potentially affecting effectiveness
Recall Initiation Date: June 16, 2025
Link: FDA Enforcement Report
Omeprazole Delayed-Release Capsules (generic for prescription-strength Prilosec)
Company: Dr. Reddy’s Laboratories
Manufacturing Location: Bachupally, India
Scope: 1,476 bottles of 1000-count capsules (20mg, Rx)
Drug Description: Short-term treatment for ulcers, Gastroesophageal Reflux Disease (GERD)
Recall Reason: Presence of foreign tablets/capsules found inside Omeprazole bottles (specifically, Divalproex Sodium extended-release 250 mg tablets)
Recall Initiation Date: June 30, 2025
Link: FDA Enforcement Report
Rizatriptan Benzoate Tablets (generic for Maxalt)
Company: Ascend Laboratories
Manufacturing Location: India (Alkem Laboratories)
Drug Description: Treats migraine headaches
Scope: Quantity not provided, affects 5 mg and 10 mg strengths
Recall Reason: Presence of nitrosamine impurities. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: July 9, 2025
Link: FDA Enforcement Report
Sucralfate Tablets (generic for Carafate)
Company: Nostrum Laboratories, Inc.
Manufacturing Location: Not specified
Scope: All lots manufactured after June 2023 that have not yet expired (approximately 60,608 bottles in two packaging formats: 100-count and 500-count bottles 1 gram strength)
Drug Description: Short-term treatment (up to 8 weeks) for peptic ulcers
Recall Reason: Company has shut down following bankruptcy filing and is unable to guarantee quality, strength, or purity for the remainder of shelf life.
Risk Statement: The company cannot assure that the product meets identity, strength, quality, or purity specifications.
Essential Extras: All lots of this product should be destroyed; Nostrum Labs is not accepting any returns of this product. Patients and healthcare providers are advised to discontinue use immediately and report any adverse effects to the FDA’s MedWatch program. No adverse events have been reported to date.
Recall Initiation Date: July 11, 2025
Link: FDA Consumer Recall Announcement
