The FDA announced on 2021-09-27 that Strides Pharma Inc. voluntarily recalled Potassium Chloride Extended-Release Tablets due to failed dissolution specifications. The recall affects 1,813 bottles distributed nationwide.
How to tell if you have it
- Brand: Strides Pharma
- Product: Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg)
- Quantity: 500 Tablets per bottle
- NDC: 64380-861-07
- Lot Code: 7240840A
- Expiration Date: 12/31/2021
- Manufacturer: Strides Shasun Limited, Bengaluru - 562106, India
- Distributor: Strides Pharma In., East Brunswick, NJ 08816
The hazard
The tablets failed dissolution specifications. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Strides Pharma Inc. has had 9 other recalls on record since 2017-05-09. Other recent recalls of similar products include Taro Recalls Children's Ibuprofen Due to Foreign Substance (2026-03-02), Strides Pharma Cinacalcet Tablets 90mg Recall: Failed Dissolution Specifications (2025-07-09), and Strides Pharma Recalls Testosterone Gel Due to Benzene Contamination (2025-03-05). Other recent recalls of similar products include Golden State Medical Recalls Prasugrel HCl 10mg Tablets (2026-08-21), Teva Metoprolol Succinate Tablets Recall: Failed Dissolution Specifications (2026-01-29), and Golden State NIACIN Extended-Release Tablets Recall: Failed Dissolution Testing (2026-05-29).