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 Carbamazepine, Fasenra, Gabapentin, Levothyroxine, Norgestimate and Ethinyl Estradiol, Prazosin, Sucralfate, and Viorele. 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
Carbamazepine Extended-Release Tablets (generic for Tegretol)
Company: American Health Packaging
Manufacturing Location: Not specified
Scope: 360 cartons (30 400 mg tablets per carton, 3×10 unit dose cards)
Drug Purpose: Prevents and treats seizures and nerve pain
Recall Reason: Failed dissolution specifications; may not dissolve effectively after storage
Recall Initiation Date: September 15, 2025
Link: FDA Enforcement Report
Fasenra (Benralizumab) Injection
Company: AstraZeneca Pharmaceuticals
Manufacturing Location: Manufactured by AstraZeneca AB, Sweden; distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE
Scope: 916 single-dose 30 mg/mL pre-filled syringes
Drug Purpose: Treats severe types of asthma that do not respond to standard asthma treatments like inhaled corticosteroids
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: October 8, 2025
Link: FDA Enforcement Report
Gabapentin Capsules (generic for Neurontin)
Company: Harvard Drug Group; packaged and distributed by Major Pharmaceuticals
Manufacturing Location: Not specified
Scope: Quantity not specified, but affects multiple lots of 100-capsule and 10-capsule blister packs of 100 mg capsules
Drug Purpose: Treats nerve pain and epilepsy
Recall Reason: Failed impurities and degradation specifications; this means the drug may contain unintended chemical substances or has broken down from its original form
Recall Initiation Date: October 10, 2025
Essential Extras: In June 2025, Harvard Drug Group initiated a separate recall for 100 mg gabapentin capsules packaged by Major Pharmaceuticals due to inadequately sealed blister packs.
Link: FDA Enforcement Report (October) and FDA Enforcement Report (June 2025 for defective blister packs)
Levothyroxine Sodium Tablets (generic for Synthroid)
Company: Accord Healthcare
Manufacturing Location: Intas Pharmaceuticals Limited, Selaqui, India
Scope: 54,432 bottles of 90-count 88 mcg tablets
Drug Purpose: Treats hypothyroidism
Recall Reason: Subpotent; the amount of active ingredient was less than the allowable range in stability testing
Recall Initiation Date: September 16, 2025
Link: FDA Enforcement Report
Norgestimate and Ethinyl Estradiol Tablets
Company: AvKARE
Manufacturing Location: Not specified
Scope: 2,192 cartons (three 28-tablet blister cards per carton)
Drug Purpose: Oral contraceptive
Recall Reason: Failed content uniformity specifications, which means the active pharmaceutical ingredient was not evenly distributed within dosage units
Recall Initiation Date: September 2, 2025
Link: FDA Enforcement Report
Prazosin Hydrochloride Capsules (generic for Minipress)
Company: Teva Pharmaceuticals USA, North Wales, PA
Manufacturing Location: Not specified
Scope: Over 580,000 bottles; multiple lots of 1 mg, 2 mg, and 5 mg capsules
Drug Purpose: Alpha blocker treatment for high blood pressure; also used off-label for post-traumatic stress disorder (PTSD)-related nightmares
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: October 7, 2025
Link: FDA Enforcement Report
Prazosin Hydrochloride Capsules (generic for Minipress)
Company: Amerisource Health Services LLC; American Health Packaging (packager)
Manufacturing Location: Not specified; product was manufactured by Teva and packaged and distributed by American Health Packaging
Scope: More than 7,000 cartons of 1mg, 2mg, and 5 mg capsules
Drug Purpose: Alpha blocker treatment for high blood pressure; also used off-label for post-traumatic stress disorder (PTSD)-related nightmares
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: October 16, 2025
Link: FDA Enforcement Report
Sucralfate Tablets (generic for Carafate)
Company: Amerisource Health; distributed by American Health Packaging
Manufacturing Location: Manufactured by Nostrum Laboratories in Kansas City, MO Scope: 27,868 blister packs (100-count 1 gram tablets)
Drug Purpose: Prevents and treats peptic (stomach) ulcers
Recall Reason: Due to Nostrum’s bankruptcy, quality cannot be assured
Recall Initiation Date: October 9, 2025
Essential Extras: In July 2025, Nostrum announced its company closure and discontinuation of quality activities. It also announced its recall of 1-gram sucralfate.
Link: FDA Enforcement Report and Nostrum Laboratories FDA Press Release
Viorele (Desogestrel and Ethinyl Estradiol Tablets)
Company: Glenmark Pharmaceuticals
Manufacturing Location: Glenmark Pharmaceuticals Limited, Goa, India
Scope: 26,928 packs (three 28-tablet blisters per pack)
Drug Purpose: Oral contraceptive
Recall Reason: Failed impurities and degradation specifications; this means the drug may contain unintended chemical substances or has broken down from its original form
Recall Initiation Date: September 3, 2025
Link: FDA Enforcement Report
