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Lower risk Drug recall · FDA · Published September 9, 2020

Pharmaceutical Associates Citalopram Oral Solution Recall: Impurities Risk

Pharmaceutical Associates recalls 20 mg/10 mL citalopram oral solution due to impurities and degradation at 9 months. Affected lots expired by April 2021. Consumers should contact pharmacy for safe alternatives.

🇺🇸 FDA recall #D-0015-2021DrugPharmaceutical Associates ›
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Recalling firmPAI Holdings, LLC. dba Pharmaceutical Associates Inc1700 Perimeter Rd · Greenville, SC 29605-5252
✎ GovInfoNow plain-language explainer

What happened, in plain English

Pharmaceutical Associates is recalling citalopram oral solution (20 mg/10 mL) because testing showed impurities and degradation after 9 months. This could lead to unsafe drug levels if used beyond the expiration date. Read more at govinfonow.com/recall/36784-pharmaceutical-associates-citalopram-oral-solution-recall-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36784-pharmaceutical-associates-citalopram-oral-solution-recall-impurities-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0015-2021

Cite this page

“Pharmaceutical Associates Citalopram Oral Solution Recall: Impurities Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36784-pharmaceutical-associates-citalopram-oral-solution-recall-impurities-risk. Based on FDA recall #D-0015-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0015-2021%22&limit=1).

Why it’s dangerous

The drug solution showed impurities and degradation at the 9-month stability test. This means the medication may not be safe after the expiration date, potentially causing unsafe drug levels.

Who’s affected

Prescription patients using the recalled citalopram oral solution. Those with the specific lot numbers listed in the recall are most at risk.

How to tell if you have this one

Check the product label for the lot numbers: C1EE (exp. 04/2021), BD82 (exp. 11/2020), BD83 (exp. 11/2020), C16D (exp. 02/2021), C563 (exp. 11/2021), or C574 (exp. 11/2021). The product is prescription-only and sold with NDC 0121-1696-40.

  • Brand
    Pharmaceutical Associates
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Pharmacy

    Speak with your pharmacy about safe alternatives for the recalled medication.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Sep 9, 202012. FDA classified it Class III: Oct 5, 202023. Published in FDA’s Enforcement Report: Oct 14, 202034. FDA terminated the recall: Feb 22, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0015-2021 (September 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0015-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA