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Unrated Drug recall · FDA · Published June 10, 2021

CIPLA Solifenacin Tablets 10mg Recall: CGMP Deviations Risk

CIPLA recalls 10mg solifenacin tablets due to manufacturing deviations. Affected lots from June 2021. Consumers should contact for details.

🇺🇸 FDA recall #D-0660-2021DrugCIPLA ›
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Recalling firmCIPLA10 Independence Blvd · Warren, NJ 07059-2730
✎ GovInfoNow plain-language explainer

CIPL: A recall of 10mg solifenacin tablets due to manufacturing deviations. This means the tablets may not be safe for use as intended. Read more at govinfonow.com/recall/36117-cipla-solifenacin-tablets-10mg-recall-cgmp-deviations-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36117-cipla-solifenacin-tablets-10mg-recall-cgmp-deviations-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0660-2021

Cite this page

“CIPLA Solifenacin Tablets 10mg Recall: CGMP Deviations Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36117-cipla-solifenacin-tablets-10mg-recall-cgmp-deviations-risk. Based on FDA recall #D-0660-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0660-2021%22&limit=1).

The FDA announced on June 10, 2021, that CIPLA voluntarily recalled Solifenacin Succinate Tablets due to CGMP deviations. The recall affects 7,228 bottles distributed nationwide.

How to tell if you have it

  • Brand: CIPLA
  • Product: Solifenacin Succinate Tablets, 10 mg, 30-count bottles
  • NDC: 69097-261-02
  • Lot #: GG90819
  • Exp. Date: 06/2021

The hazard

The recall is due to Current Good Manufacturing Practice (CGMP) deviations, according to the FDA.

Context

GovInfoNow's records show CIPLA has 7 other recalls on record since December 14, 2020. Other recent recalls of similar products include Cipla Arformoterol Inhaler Recall (September 29, 2022), Cipla Budesonide Inhaler Recall (September 15, 2022), and CIPLA Difluprednate Eye Drops Recall (August 22, 2022). Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Recall (April 1, 2026) and Ajanta Pharma Fenofibrate Capsules Recall (May 28, 2026).

How to tell if you have this one

Check for the lot number GG90819 on the bottle. The product was manufactured for Cipla USA, Inc. in Sunrise, Florida, and expires June 2021.

  • Brand
    CIPLA
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number GG90819 on the bottle label.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Jun 10, 202112. FDA classified it Class II: Jul 15, 202123. Published in FDA’s Enforcement Report: Jul 21, 202134. FDA terminated the recall: Jan 10, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  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-0660-2021 (June 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0660-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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