Recall RadarDuloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Ajanta Pharma Ltd. — Aurangabad
- Severity
- Class II — moderate
- Reported
- May 13, 2026
- Quantity
- 117,168 packs
- Recall number
- D-0516-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide within U.S
Other medicine & devices recalls
-
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC…
Class I — serious · FDA · August 12, 2026 · Sunny Pharmtech Inc.
-
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC…
Class I — serious · FDA · August 12, 2026 · Sunny Pharmtech Inc.
-
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in I…
Class II — moderate · FDA · August 12, 2026 · Aurobindo Pharma USA Inc
-
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (US…
Class II — moderate · FDA · August 12, 2026 · Zydus Pharmaceuticals (USA) Inc
-
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Cen…
Class III — low · FDA · August 12, 2026 · Central Admixture Pharmacy Services Inc
-
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Class II — moderate · FDA · August 5, 2026 · Glenmark Pharmaceuticals Inc., USA
-
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in…
Class II — moderate · FDA · August 5, 2026 · MYLAN PHARMACEUTICALS INC
-
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., S…
Class II — moderate · FDA · August 5, 2026 · MICRO LABS USA INC