FDA drug recalls · openFDA

Is POTASSIUM CHLORIDE recalled?

The FDA has recorded 11 recalls of POTASSIUM CHLORIDE (2024–2025) , recalled under brand like POTASSIUM CHLORIDE. 10 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of POTASSIUM CHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Failed Dissolution Specifications 3

CGMP Deviations 2

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE 2

Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dot 1

Failed Dissolution Specifications. 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Class I ongoing

ICU Medical, Inc. 2025-02-13 lots: Lot 1023172, Exp Date: 31 January 2026

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Class I ongoing

Otsuka ICU Medical LLC 2025-10-29 lots: Lot # 1030613, Exp Date: 09/30/2026

POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Class I ongoing

Otsuka ICU Medical LLC 2025-10-29 lots: Lot # 1030613, Exp Date: 09/30/2026

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lak Class I ongoing

ICU Medical, Inc. 2025-02-13 lots: Lot 1023172, Exp Date: 31 January 2026

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-co Class I ongoing

Amerisource Health Services LLC 2024-06-25 lots: [100 count bottles]: Lot 17221738, Exp 07/31/2024; Lot 17222494, Exp 10/31/2024; Lot 17230533, Exp 01/31/2025; Lot 17232208, Exp 09/30/2025; [500 count bottles]: Lot 17221823, Lot 17221830, Exp 07/31/2024; Lot 17221831, Exp 08/31/2024; Lot 17230248, Lot 17230253, Lot 17230271, Exp 12/31/2024; Lot 17230796, Lot 17230820, Exp 02/28/2025; Lot 17230825, Lot 17230833, Lot 17230840, Exp 03/31/2025; Lot 17231537, Lot 17231540, Lot 17231719, Lot 17231737, Exp 06/30/2025; Lot 17232111, Lot 17232164, Exp 09/30/2025

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma Class I ongoing

Glenmark Pharmaceuticals Inc., USA 2024-05-30 lots: Lot #: 17221197, 17221386, 17221385, Exp May-31-24; 17221489, 17221504, 17221530, Exp Jun-30-24; 17221561, 17221579, 17221568, 17221702, 17221704, Exp Jul-31-24; 17221898, 17221993, 17222029, Exp Aug-31-24; 17222300, 17222304, 17222278, 17222609, 17222395, Exp Oct-31-24; 17222589, 17222605, 17222613, Exp Nov-30-24;

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma Class I ongoing

Glenmark Pharmaceuticals Inc., USA 2024-05-30 lots: Lot#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17221566, 17221719, 17221731, Exp Jul-31-24; 17221891, 17221892, 17221900, 17221992, 17222022, Exp Aug-31-24; 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, Exp Sep-30-24; 17222265, 17222269, Exp Oct-31-24; 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067, Exp Nov-30-24;

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Class II ongoing

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-01-30 lots: Lot# T05224; Exp. 02/2026

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Class II Terminated

B. Braun Medical Inc 2024-03-06 lots: Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma Class II ongoing

Glenmark Pharmaceuticals Inc., USA 2024-05-30 lots: Lot #: 17230074, 17230221, Exp Dec-31-24; 17230468, 17230479, 17230553, 17230543, 17230561, Exp Jan-31-25; 17230619, 17230624, Exp Feb-28-25; 17230879, 17230890, 17230918, 17230984, 17230996, 17231002, 17231081, Exp Mar-31-25; 17231102, 17231135, 17231329, Exp Apr-30-25; 17231369, 17231513, Exp May-31-24; 17231516, 17231713, Exp Jun-30-25; 17231909, 17231903, Exp Jul-31-25; 17231943, Exp Aug-31-25; 17232166, 17232179, Exp Sep-30-25.

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma Class II ongoing

Glenmark Pharmaceuticals Inc., USA 2024-05-30 lots: Lot #: 17230186, 17230192, 17230213, 17230278, 17230399, Exp Dec-31-24; 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, Exp Jan-31-25; 17230574, 17230585, 17230608, 17230629, Exp Feb-28-25; 17230883, 17230921, Exp Mar-31-25; 17231087, 17231339, Exp Apr-30-25; 17231360, Exp May-31-25; 17231711, 17231745, Exp Jun-30-25; 17231819, 17231820, 17231936, 17231957, Exp Jul-31-25; 17231998, 17232012, Aug-31-25; 17232110, Exp Sep-30-25; 17232114, Exp Aug-31-25; 17232119, 17232343, Exp Sep-30-25.

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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