Food, drugs, devices › Preferred Pharmaceuticals, Inc.

Drug recall: Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

FDA enforcement event 90148 · Class II · initiated 3 May 2022 · status Terminated · terminated 21 Sep 2022

DrugVoluntary: Firm initiated2 product recordsAnaheim, CA

FDA enforcement event 90148 is a drug recall by Preferred Pharmaceuticals, Inc. of Anaheim, CA, initiated 3 May 2022 and classified Class II, with 2 product records.

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. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 21 Sep 2022. Initiation: voluntary: firm initiated. Preferred Pharmaceuticals, Inc. has 32 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

Preferred Pharmaceuticals, Inc., Anaheim, CA.

Reason for recall

"CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits"

Distribution

"Within the U.S in FL and CA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0891-2022	Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.	31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).	Class II	Terminated	1 Jun 2022
D-0892-2022	Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.	47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).	Class II	Terminated	1 Jun 2022

Context

65%of 2022 drug events are Class II325 events that year

2product records in this eventfirm median: 1

32events on this register for the firm

Other enforcement events for Preferred Pharmaceuticals, Inc.

Initiated	Product (first record)	Type	Class	Records
25 Mar 2026	Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg	Drug	Class II	1
17 Nov 2025	Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred	Drug	Class II	1
18 Apr 2025	Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC	Drug	Class II	1
8 Aug 2024	Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisi	Drug	Class II	1
10 May 2024	Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03	Drug	Class II	1
26 Jun 2023	Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-	Drug	Class II	1
27 Mar 2023	Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenrid	Drug	Class II	3
23 Mar 2023	Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27	Drug	Class II	17
16 Jan 2023	Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharma	Drug	Class II	1
12 Apr 2022	Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.	Drug	Class II	1

All 32 events for Preferred Pharmaceuticals, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits"

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: "Within the U.S in FL and CA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Sep 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.