Recall Record

Anaheim, CA, United States

Preferred Pharmaceuticals, Inc. recalls

33 recalls recorded since 2018, most recently on 28 September 2026. 11 are listed as ongoing. Status and classification are as published by the FDA.

Recalls33
Ongoing (FDA)11
Terminated or completed22
Class I (FDA)0

Ongoing Class II Drugs

Recall started
28 September 2026
Reason
Failed Content Uniformity Specifications
Distribution
USA Nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-0013-2027

Ongoing Class II Drugs

Recall started
25 March 2026
Reason
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0443-2026

Ongoing Class II Drugs

Recall started
17 November 2025
Reason
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.
Distribution
Natinowide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0239-2026

Ongoing Class II Drugs

Recall started
18 April 2025
Reason
cGMP Deviations
Distribution
Nationwide in the US
Initiated
Voluntary: Firm initiated
Recall number
D-0391-2025

Ongoing Class II Drugs

Recall started
8 August 2024
Reason
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Distribution
CA and NV
Initiated
Voluntary: Firm initiated
Recall number
D-0647-2024

Ongoing Class II Drugs

Recall started
10 May 2024
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution
Product distributed to CA, FL, OK, KS and CT
Initiated
Voluntary: Firm initiated
Recall number
D-0505-2024

Ongoing Class II Drugs

Recall started
26 June 2023
Reason
Failed Stability Specifications
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0894-2023

Terminated Class II Drugs

Recall started
27 March 2023
Terminated
24 October 2023
Reason
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0504-2023, D-0506-2023, D-0505-2023

Ongoing Class II Drugs

Recall started
23 March 2023
Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Distribution
USA Nationwide
Initiated
Voluntary: Firm initiated
Recall numbers
D-0515-2023, D-0527-2023, D-0511-2023, D-0523-2023, D-0520-2023, D-0526-2023, D-0518-2023, D-0512-2023, D-0521-2023, D-0522-2023, D-0517-2023, D-0524-2023 and 5 more

Terminated Class II Drugs

Recall started
16 January 2023
Terminated
14 April 2023
Reason
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.
Distribution
IN
Initiated
Voluntary: Firm initiated
Recall number
D-0173-2023

Terminated Class II Drugs

Recall started
3 May 2022
Terminated
21 September 2022
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution
Within the U.S in FL and CA.
Initiated
Voluntary: Firm initiated
Recall numbers
D-0891-2022, D-0892-2022

Terminated Class II Drugs

Recall started
12 April 2022
Terminated
22 September 2022
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Distribution
Nationwide within the U.S to CA, IN and FL.
Initiated
Voluntary: Firm initiated
Recall number
D-0789-2022

Terminated Class II Drugs

Recall started
28 March 2022
Terminated
10 May 2022
Reason
Out of specification results observed in dissolution during long term stability testing.
Distribution
Nationwide in the USA and CA.
Initiated
Voluntary: Firm initiated
Recall number
D-0769-2022

Terminated Class II Drugs

Recall started
24 March 2022
Terminated
17 November 2023
Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Distribution
Product distributed in California and Florida.
Initiated
Voluntary: Firm initiated
Recall number
D-0771-2022

Terminated Class II Drugs

Recall started
24 March 2022
Terminated
25 October 2023
Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Distribution
Nationwide within the USA.
Initiated
Voluntary: Firm initiated
Recall number
D-0773-2022

Terminated Class II Drugs

Recall started
23 March 2022
Terminated
4 May 2023
Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Distribution
IL
Initiated
Voluntary: Firm initiated
Recall number
D-0768-2022

Terminated Class II Drugs

Recall started
22 February 2022
Terminated
5 May 2023
Reason
CGMP deviations
Distribution
Nationwide in the USA.
Initiated
Voluntary: Firm initiated
Recall number
D-0642-2022

Ongoing Class II Drugs

Recall started
29 November 2021
Reason
Defective container: Out of specification for container integrity leading to bottles leaking.
Distribution
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
Initiated
Voluntary: Firm initiated
Recall number
D-0278-2022

Ongoing Class II Drugs

Recall started
28 April 2021
Reason
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Distribution
Distributed to two physician consignees located in FL.
Initiated
Voluntary: Firm initiated
Recall number
D-0385-2021

Ongoing Class II Drugs

Recall started
12 April 2021
Reason
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Distribution
recalled product was distributed to three physicians located CA
Initiated
Voluntary: Firm initiated
Recall number
D-0342-2021

Terminated Class II Drugs

Recall started
1 November 2020
Terminated
20 May 2024
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
Distributed to two physician's offices located in FL.
Initiated
Voluntary: Firm initiated
Recall number
D-0077-2021

Terminated Class II Drugs

Recall started
2 September 2020
Terminated
25 April 2024
Reason
CGMP Deviations
Distribution
Repackaged tablets sold to three physicians located in CA and GA.
Initiated
Voluntary: Firm initiated
Recall numbers
D-1623-2020, D-1621-2020, D-1624-2020, D-1622-2020

Terminated Class II Drugs

Recall started
1 July 2020
Terminated
17 April 2024
Reason
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Distribution
Nationwide within the U.S.
Initiated
Voluntary: Firm initiated
Recall number
D-1390-2020

Terminated Class II Drugs

Recall started
17 June 2020
Terminated
21 March 2024
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
Product was distributed to two medical clinics located in FL.
Initiated
Voluntary: Firm initiated
Recall number
D-1364-2020

Terminated Class II Drugs

Recall started
7 January 2020
Terminated
14 December 2023
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Initiated
Voluntary: Firm initiated
Recall numbers
D-0797-2020, D-0796-2020

Terminated Class II Drugs

Recall started
2 December 2019
Terminated
9 May 2023
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
CA, FL
Initiated
Voluntary: Firm initiated
Recall number
D-0617-2020

Terminated Class II Drugs

Recall started
21 November 2019
Terminated
11 May 2023
Reason
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Distribution
CA, FL, IL
Initiated
Voluntary: Firm initiated
Recall number
D-0531-2020

Terminated Class II Drugs

Recall started
29 August 2019
Terminated
24 April 2023
Reason
Failed Impurities/Degradation Specifications
Distribution
Product was distributed to 1 physician in Gainesville Florida.
Initiated
Voluntary: Firm initiated
Recall number
D-1877-2019

Terminated Class II Drugs

Recall started
18 July 2019
Terminated
24 April 2023
Reason
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Distribution
CA, FL
Initiated
Voluntary: Firm initiated
Recall number
D-1491-2019

Terminated Class II Drugs

Recall started
10 June 2019
Terminated
3 April 2023
Reason
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution
Distribution was made to CA and FL.
Initiated
Voluntary: Firm initiated
Recall number
D-1410-2019

Terminated Class II Drugs

Recall started
30 April 2019
Terminated
3 April 2023
Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Distribution
CA, GA, IN. No DOD/VA accounts. No foreign accounts.
Initiated
Voluntary: Firm initiated
Recall number
D-1281-2019

Terminated Class II Drugs

Recall started
6 March 2019
Terminated
30 March 2023
Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Distribution
California, Georgia, Indiana
Initiated
Voluntary: Firm initiated
Recall number
D-1051-2019

Terminated Class II Drugs

Recall started
15 August 2018
Terminated
18 January 2019
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Initiated
Voluntary: Firm initiated
Recall number
D-1107-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.