August 2026: Huge Recall of 162,000 Vials of Compounded Semaglutide by Apollo Care Due to Contamination With Nylon and Silk Protein Particles; Trokendi XR, Azelaic Gel, Dabigatran, Divalproex Recalls
Dear Readers, We have more news than usual to report this week, so the newsletter will be sent in two parts. This section features drug recalls; the second section, to be sent tomorrow, features five notable drug approvals, pharmacy and research news, and medication tips.
Compounded Semaglutide Recall by Apollo Care
Apollo Care, LLC (Columbia, Missouri), an FDA registered 503B outsourcing (bulk) compounding pharmacy, is recalling more than 162,000 multidose vials of semaglutide (six products expiring in August, November, and December 2026) and semaglutide/glycine combination (5 products expiring in December 2026) due to the presence of particulate matter in the vials. Semaglutide is the active ingredient in Novo Nordisk’s diabetes drug Ozempic and weight loss drug Wegovy. Compounded semaglutide with glycine also contains the dietary supplement glycine, which is said to help preserve muscle mass during weight loss.
The particulate matter in the vials was identified as a nylon/polyamide and silk protein material. This is a nationwide recall. If you use compounded semaglutide obtained from an online source or that might be a private label, check with your provider to find out if it the supplier was Apollo Care. Also, look closely in your vial for visible particles. Check the enforcement report link below for lot numbers, product strengths, and expiration dates.
FDA Enforcement Report
The FDA’s directory of compounding facilities indicates there was an inspection on July 28, 2026 and an inspection report Form FDA 483 was issued, but has not been made public. In February 2026, Apollo Health (Columbia, Missouri) received a warning letter from the FDA about manufacturing facility violations noted in a 2025 inspection.
Quality problems at compounding pharmacies are not new. Recently, three other compounding pharmacies have been warned for quality oversight violations and there have been other recalls of compounded semaglutide.
MedShadow Foundation: “FDA Drug Recalls and Warnings: Compounding Pharmacies Cited for Unsanitary Conditions and Safety Lapses”
Azelaic Acid Acne Gel Recall by Glenmark
Glenmark is recalling five lots of prescription Azelaic Acid Gel, 15%, 50 gram tubes, because of product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy). The acne and rosacea skin treatment gel was made in Colvale-Bardez, Goa, India with an expiration date of February, March, or April 2028.
FDA Enforcement Report
Note: In October 2026, Glenmark recalled 13,824 tubes for the same reason: market complaints of a gritty grainy texture.
Cyproheptadine Hydrochloride Syrup Recall by Rising Pharma
Rising Pharma is recalling 74,208 bottles of Cyproheptadine Hydrochloride Syrup (generic for PERIACTIN) because the medication was crystallizing, with particles floating in the bottle. This is prescription antihistamine treats allergy symptoms and is used off-label to stimulate appetite.
Most of the patients leaving reviews on Ask a Patient website took this medication to stimulate appetite for weight gain.
Dabigatran Etexilate Capsules by Ascend Laboratories
Ascend Laboratories is recalling 1,753 cartons (60-count per carton), 110 mg strength; 2,717 cartons (20-count per carton), 150 mg strength of blood thinner Dabigatran Etexilate (Pradaxa generic) capsules due to failed impurities and degradation specifications; an out-of-specification result was observed for impurities during 12-month long-term stability testing. The medication was made in Mumbai India and distributed by Major Pharmaceuticals.
FDA Enforcement Report
Divalproex Sodium Delayed-Release Tablets Recall by Bionpharma Inc.
Bionpharma is recalling an unspecified quantity of 500-tablet bottles 500 mg strength divalproex tablets (Depakote generic) due to the presence of foreign tablets/capsules (foreign tablets not identified). Made in India, this is an anticonvulsant (seizure), bipolar disorder drug, and migraine prevention drug. Expiration date is December 2028.
FDA Enforcement Report
Glaucoma Eye Drops Recall by Micro Labs USA
Micro Labs is recalling 10ml bottles of glaucoma treatment Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, due to defective containers. There were reports of broken cap spikes and undeliverable drops. The drops expire 06/30/2027.
Mirabegron Tablets Recall by Zydus
Zydus Pharmaceuticals is recalling one lot of overactive bladder treatment Mirabegron Extended-Release Tablets, 25 mg, 30-count bottles due to potential presence of nitrosamine impurities, a carcinogenic substance, above the acceptable level. The tablets expire in November 2026. Mirabegron is a generic version of Myrbetriq.
FDA Enforcement Report
Mirabegron reviews for overactive bladder at Ask a Patient
Trokendi XR Capsules Recall by Supernus
Supernus Pharma is recalling 30-count bottles of epilepsy and migraine drug 25 mg Trokendi XR (topiramate extended release) because of problems with the medication dissolving properly. The capsules were made in Winchester, Kentucky by Catalent Pharma Solutions.
FDA Enforcement Report
Did you miss our last edition from July 26? View it here:
July 2026: Huge Cetirizine, Amlodipine, Nystatin, Eye Drops Recalls; Pediatric Approvals; Eye Drops Tips; New Cholesterol Treatment; Blood Test News
Rising Pharma Cetirizine (Zyrtec generic) Recall Due to Cross-Contamination
Here is a gallery of today’s featured drug recalls:
