SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St,…
Presence of foreign substance: identified as aluminum.
Read the official notice →- Date
- 2025-08-13
- Country
- United States
- Brand
- Sun Pharmaceutical Industries
- Product
- Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124,…
- Classification
- Class II
- Units
- USA Nationwide
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Sun Pharmaceutical Industries recalls
- 2026-01-21
USSUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.,…
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- 2025-11-05
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick,…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- 2025-09-24
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc.…
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
- 2025-07-23
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCRecalled units were distributed to 17 distributors who may have further…Official notice → - 2025-04-16
- US
- 2025-03-12
- US
Other drugs & medical recalls in the United States
- 2025-08-13
- US
CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
FDA · DeviceCareFusion 303, Inc.US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA…Official notice → - US
B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air…
FDA · DeviceB BRAUN MEDICAL INCUS distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN,…Official notice → - US
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- US
Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- US
Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.,…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- US
Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.