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Unrated Drug recall · FDA · Published December 22, 2020

Strides Pharma Tacrolimus Capsules Recall: Failed Moisture Limits

Strides Pharma recalls 1mg Tacrolimus capsules due to failed moisture limits. This may affect drug stability and safety. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0180-2021DrugStrides Pharma ›
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Contact the company

Recalling firmStrides Pharma Inc.2 Tower Center Blvd Ste 1102 · East Brunswick, NJ 08816-1100
✎ GovInfoNow plain-language explainer

Strides Pharma is recalling 1mg Tacrolim: 100 capsules (NDC 64380-721-06) because they may have failed moisture limits. This could affect the drug's stability and safety, so affected users should contact the manufacturer. Read more at govinfonow.com/recall/36569-strides-pharma-tacrolimus-capsules-recall-failed-moisture-limits.

Source Summary by GovInfoNow · govinfonow.com/recall/36569-strides-pharma-tacrolimus-capsules-recall-failed-moisture-limits · Updated October 4, 2026 · FDA enforcement record: FDA #D-0180-2021

Cite this page

“Strides Pharma Tacrolimus Capsules Recall: Failed Moisture Limits.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36569-strides-pharma-tacrolimus-capsules-recall-failed-moisture-limits. Based on FDA recall #D-0180-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0180-2021%22&limit=1).

The FDA announced on Dec. 22, 2020, that Strides Pharma Inc. voluntarily recalled NDC 64380-721-06 TACROLIMUS CAPSULES due to failed moisture limits. The recall affects 960 bottles distributed in Pennsylvania. The status is terminated.

How to tell if you have it

  • Brand: Strides Pharma
  • Product: NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only
  • Lot code: 7242728A
  • Distribution date: June 2023
  • Quantity: 960 bottles
  • Distribution area: PA

The hazard

The product failed moisture limits. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Strides Pharma Inc. has 9 other recalls on record since May 9, 2017. Other recent recalls of similar products include Taro Recalls Children's Ibuprofen Due to Foreign Substance (March 2, 2026), Sun Pharmaceutical Lisdexamfetamine Capsules Recall: Failed Dissolution Test (Oct. 28, 2025), and Shoolin Pharma Chem Tadalafil Recall: FDA Inspection Findings (Aug. 3, 2026).

How to tell if you have this one

Check for the NDC code 64380-721-06 on the packaging. The capsules are 1mg Tacrolimus, prescription-only, manufactured by Strides Pharma Science Ltd. in Bengaluru, India, and distributed by Strides Pharma Inc. in New Jersey.

  • Brand
    Strides Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Strides Pharma Inc. for specific instructions on handling the recalled product.

Where it went and when

Where it was distributed

Distributed in Pennsylvania.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

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

States: Pennsylvania.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Dec 22, 202012. FDA classified it Class III: Dec 30, 202023. Published in FDA’s Enforcement Report: Jan 6, 202134. FDA terminated the recall: Jan 26, 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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Other Strides Pharma recalls

STRIDES PHARMA INC recalls Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro
March 2, 2026

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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-0180-2021 (December 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0180-2021 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