The Recall Desk

Manufacturer

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

7 recalls in our database name PAI Holdings, LLC. dba Pharmaceutical Associates Inc as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2025-02-12

Of the 7 recalls from PAI Holdings, LLC. dba Pharmaceutical Associates Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • ModerateFDA (Drugs)·D-0222-2025·2025-02-12

    Guaifenesin and Codeine Cough Syrup Recalled for Superpotent Strength

    PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.

    Product
    GUAIFENESIN AND CODEINE PHOSPHATE — GUAIFENESIN AND CODEINE PHOSPHATE (GUAIFENESIN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0721-2021·2021-08-18

    Nystatin Oral Suspension Recalled Due to CGMP Violation

    PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0722-2021·2021-08-18

    Cimetidine Hydrochloride Oral Solution Recalled for CGMP Violation

    Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.

    Product
    Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0723-2021·2021-08-18

    Ethosuximide Oral Solution Recalled Due to Lack of CGMP Compliance

    PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.

    Product
    ETHOSUXIMIDE — ETHOSUXIMIDE (ETHOSUXIMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0015-2021·2020-10-14

    Pharmaceutical Associates Recalls Citalopram Oral Solution Due to Impurities

    Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution due to high impurity levels found during stability testing.

    Product
    Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1494-2020·2020-08-19

    FDA Recalls Nystatin Oral Suspension Due to Subpotent Drug Levels

    Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension because it failed potency testing. Patients should consult their healthcare provider.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2020·2020-04-01

    Nystatin Oral Suspension Recalled for Low Potency

    Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension because it tested below the required potency level.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide