Food, drugs, devices › Strides Pharma Inc.

Drug recall: Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun

FDA enforcement event 88759 · Class II · initiated 27 Sep 2021 · status Terminated · terminated 26 Oct 2022

DrugVoluntary: Firm initiated1 product recordEast Brunswick, NJ

Strides Pharma Inc. (East Brunswick, NJ) initiated this drug recall on 27 Sep 2021; FDA lists 1 product record under event 88759, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 299 drug enforcement events initiated in 2021 carry the same class.

Status: Terminated, terminated 26 Oct 2022. Initiation: voluntary: firm initiated. Strides Pharma Inc. has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Strides Pharma Inc., East Brunswick, NJ.

Reason for recall

"Failed Dissolution Specifications"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0006-2022	Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.	1813 bottles	Class II	Terminated	20 Oct 2021

Context

60%of 2021 drug events are Class II299 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Strides Pharma Inc.

Initiated	Product (first record)	Type	Class	Records
2 Mar 2026	Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceutica	Drug	Class II	1
9 Jul 2025	Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Dis	Drug	Class II	1
5 Mar 2025	Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Bru	Drug	Class II	2
29 Dec 2023	Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 56210	Drug	Class II	1
26 Jun 2023	Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Scie	Drug	Class II	1
19 Jul 2022	Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 5621	Drug	Class II	1
18 May 2022	Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 1	Drug	Class II	3
22 Dec 2020	NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengalur	Drug	Class III	1
9 May 2017	Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India	Drug	Class III	1

All 10 events for Strides Pharma Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specifications"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Oct 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.