Preferred Pharmaceuticals, Inc.

Preferred Pharmaceuticals, Inc.: 55 FDA recall reports

Every drug recall the FDA has published for Preferred Pharmaceuticals, Inc.. The fault, and how the agency graded it.

55Reports
0Class I
26Ongoing
2026-04-15Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II55

By year reported

YearReports
20181
20197
20209
20213
20228
202322
20242
20252
20261
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bo

D-0443-2026  ·  Class II  ·  reported 2026-04-15  ·  Ongoing

Why it was recalled
Lack of Assurance of Sterility
Product
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
Where it went
Nationwide within the United States
How much
720 bottles

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged b

D-0239-2026  ·  Class II  ·  reported 2025-12-24  ·  Ongoing

Why it was recalled
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Product
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
Where it went
Natinowide in the USA
How much
575 1x10 Foil Blister Packs

Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Li

D-0391-2025  ·  Class II  ·  reported 2025-05-07  ·  Ongoing

Why it was recalled
cGMP Deviations
Product
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
Where it went
Nationwide in the US
How much
1190 Bottles

Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratori

D-0647-2024  ·  Class II  ·  reported 2024-09-04  ·  Ongoing

Why it was recalled
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Product
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Where it went
CA and NV
How much
266 bottles

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9

D-0505-2024  ·  Class II  ·  reported 2024-05-29  ·  Ongoing

Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Where it went
Product distributed to CA, FL, OK, KS and CT
How much
66 bottles of 30 tablets

Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (N

D-0894-2023  ·  Class II  ·  reported 2023-07-12  ·  Ongoing

Why it was recalled
Failed Stability Specifications
Product
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.
Where it went
Nationwide within the United States
How much
541 Bottles

Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 277

D-0515-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
Where it went
USA Nationwide
How much
4 Bottles

Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 277

D-0527-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Where it went
USA Nationwide
How much
15 Bottles

Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Dur

D-0511-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
Where it went
USA Nationwide
How much
158 Bottles

Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham,

D-0523-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Where it went
USA Nationwide
How much
57 Bottles

Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27

D-0520-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Where it went
USA Nationwide
How much
264 Bottles

Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by:

D-0504-2023  ·  Class II  ·  reported 2023-04-12  ·  Terminated

Why it was recalled
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Product
Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
Where it went
Nationwide in the USA
How much
30 Bottles

Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC

D-0526-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
Where it went
USA Nationwide
How much
32 Bottles

Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle

D-0518-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Where it went
USA Nationwide
How much
a) 266 Bottles, b) not reported, c) 216 Bottles

Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bott

D-0512-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
Where it went
USA Nationwide
How much
a) 375 Bottles b) 323 Bottles

Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC687

D-0506-2023  ·  Class II  ·  reported 2023-04-12  ·  Terminated

Why it was recalled
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Product
Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
Where it went
Nationwide in the USA
How much
33 x 30-count; 78 x 60-count bottles

Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., D

D-0521-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
Where it went
USA Nationwide
How much
24 Bottles

Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham,

D-0522-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
Where it went
USA Nationwide
How much
82 Bottles of 90 Tablets

Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27

D-0517-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
Where it went
USA Nationwide
How much
17 Bottles

Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 6

D-0524-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Where it went
USA Nationwide
How much
a) 305 Bottles, b) 72 Bottles, c) 617 Bottles

Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 2

D-0513-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
Where it went
USA Nationwide
How much
72 Bottles

Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 277

D-0514-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
Where it went
USA Nationwide
How much
3 Bottles

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 6

D-0525-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Where it went
USA Nationwide
How much
a) 88 Bottles, b) 3 Bottles, c) 175 Bottles

Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC

D-0505-2023  ·  Class II  ·  reported 2023-04-12  ·  Terminated

Why it was recalled
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Product
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
Where it went
Nationwide in the USA
How much
320 x 30-count; 46 x 60-count; 10 x 90-count bottles

Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC

D-0519-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Where it went
USA Nationwide
How much
a) 59 Bottles, b) 77 Bottles

Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC

D-0516-2023  ·  Class II  ·  reported 2023-04-12  ·  Ongoing

Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Where it went
USA Nationwide
How much
a) 135 Bottles, b) 24 Bottles

Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFER

D-0173-2023  ·  Class II  ·  reported 2023-02-01  ·  Terminated

Why it was recalled
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Product
Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09.
Where it went
IN
How much
9 bottles

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

D-0891-2022  ·  Class II  ·  reported 2022-06-01  ·  Terminated

Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
Where it went
Within the U.S in FL and CA.
How much
31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758

D-0892-2022  ·  Class II  ·  reported 2022-06-01  ·  Terminated

Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Where it went
Within the U.S in FL and CA.
How much
47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).

Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, I

D-0789-2022  ·  Class II  ·  reported 2022-05-04  ·  Terminated

Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Product
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Where it went
Nationwide within the U.S to CA, IN and FL.
How much
44 Bottles of 90 Tablets 33 Bottles of 30 Tablets

Showing the 30 most recent of 55. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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