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Unrated Drug recall · FDA · Published May 19, 2016

Galderma Recalls Doxycycline Capsules Due to Labeling Errors

Galderma recalls Doxycycline USP Capsules 40 mg because some bottles have missing or incorrect lot numbers and expiration dates.

🇺🇸 FDA recall #D-1031-2016DrugGalderma / Prasco ›
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Recalling firmGalderma Laboratories, L.P.14501 N Freeway Tx · Fort Worth, TX 76177
✎ GovInfoNow plain-language explainer

What happened, in plain English

Galderma Laboratories, L.P. is recalling Doxycycline, USP Capsules 40 mg because the labeling on some bottles has incorrect or missing lot numbers and/or expiration dates. The product is packaged in 30-count bottles and marketed by Prasco Laboratories. This recall affects 71,340 bottles distributed nationwide. Read more at govinfonow.com/recall/42605-galderma-recalls-doxycycline-capsules-due-to-labeling-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/42605-galderma-recalls-doxycycline-capsules-due-to-labeling-errors · Updated October 9, 2026 · FDA enforcement record: FDA #D-1031-2016

Cite this page

“Galderma Recalls Doxycycline Capsules Due to Labeling Errors.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42605-galderma-recalls-doxycycline-capsules-due-to-labeling-errors. Based on FDA recall #D-1031-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1031-2016%22&limit=1).

Why it’s dangerous

The primary issue is that some bottles lack valid lot numbers or expiration dates, which prevents users and healthcare providers from verifying the medication's freshness and authenticity. While the record does not specify a direct physical injury mechanism like fire or choking, incorrect labeling can lead to the use of expired medication or difficulty in tracking adverse events.

Who’s affected

Consumers who purchased Doxycycline USP Capsules 40 mg from pharmacies or retailers across the United States between the manufacture dates and the recall date. Patients relying on these specific lots may be affected if they cannot verify the expiration date.

How to tell if you have this one

Check your bottle of Doxycycline, USP Capsules 40 mg (Rx Only) for the NDC number 66993-815-30. Look specifically at the label for Lot numbers and Expiration dates; some bottles may have these fields blank or incorrect. Affected lots include Lot # 1496059A with an expiry of 08/31/2017 and Lot # AD9848A with an expiry of 11/30/2017.

  • Brand
    Galderma / Prasco
  • Category
    Drug

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: “U.S. 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 7 months after the firm started it.

1. Firm started the recall: May 19, 201612. FDA classified it Class III: Jun 14, 201623. Published in FDA’s Enforcement Report: Jun 22, 201634. FDA terminated the recall: Dec 23, 201642016
  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-1031-2016 (May 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1031-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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