CLASS III Drug recall · Reported 14 Oct 2020 · FDA Enforcement Report
Citalopram Oral Solution, USP 20 mg/ unit dose cups recalled
PAI Holdings is recalling Citalopram Oral Solution, USP 20 mg/ unit dose cups, distributed nationwide in the US. The recall was initiated on 9 Sep 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0015-2021
- FDA event ID
- 86409
- Recalling firm
- PAI Holdings, Greenville, SC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Sep 2020
- FDA classified
- 5 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 9 Sep 2020 | Recall initiated by company | |
| 5 Oct 2020 | Classified by FDA | +26 days |
| 14 Oct 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Which lots are affected?
Lots: C1EE Exp. 04/2021, BD82 Exp. 11/2020, BD83 Exp. 11/2020, C16D Exp. 02/2021, C563 Exp. 11/2021, C574 Exp. 11/2021
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PAI Holdings
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Sorbitol Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Aqueous Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Sorbitol Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Aqueous Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS III | Guaifenesin and Codeine Phosphate Oral Solution recalled by PAI HoldingsGuaifenesin And Codeine Phosphate | PAI Holdings | Potency & Assay | OH |
Other Citalopram recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Citalopram Tablets, USP, 20MG recalled by Cardinal HealthcareCitalopram | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Citalopram Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Citalopram tablets USP, 20mg recalled by Dr. Reddy's Laboratories | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Citalopram tablets USP, 10mg recalled by Dr. Reddy's Laboratories | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Citalopram tablets USP, 40mg recalled by Dr. Reddy's Laboratories | Dr. Reddy's Laboratories | Other | Nationwide |