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Unrated Drug recall · FDA · Published February 12, 2016

Apace Recalls Minocycline Capsules Due to Labeling Errors

Apace KY LLC recalls Minocycline Hydrochloride Capsules USP, 100 mg due to incorrect lot numbers on unit dose blisters. Check your medication packaging.

🇺🇸 FDA recall #D-0811-2016DrugApace KY LLC ›
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Recalling firmApace KY LLC12954 Fountain Run Rd · Fountain Run, KY 42133-7914
✎ GovInfoNow plain-language explainer

What happened, in plain English

Apace KY LLC is recalling Minocycline Hydrochloride Capsules USP, 100 mg because the individual unit dose blisters are mislabeled with an incorrect lot number (13560) instead of the correct one (13650). This labeling error affects 291 cartons distributed nationwide. The record does not specify a remedy or health risk associated with this labeling discrepancy. Read more at govinfonow.com/recall/43152-apace-recalls-minocycline-capsules-due-to-labeling-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/43152-apace-recalls-minocycline-capsules-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0811-2016

Cite this page

“Apace Recalls Minocycline Capsules Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43152-apace-recalls-minocycline-capsules-due-to-labeling-errors. Based on FDA recall #D-0811-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0811-2016%22&limit=1).

Why it’s dangerous

The hazard is a labeling error where the blister packs display lot number 13560 instead of the correct lot number 13650. The provided record does not explain why this discrepancy is dangerous or what health risks it poses.

Who’s affected

Patients who have been prescribed Minocycline Hydrochloride Capsules USP, 100 mg from the affected lots and purchased them anywhere in the United States. The record does not specify which patients are at risk or if any injuries occurred.

How to tell if you have this one

Check for Minocycline Hydrochloride Capsules USP, 100 mg in 30-count (3 x 10) unit dose blisters. Look for NDC 50268-569-11 on the blister and NDC 50268-569-13 on the carton. Verify if the blister lot number is 13560 while the outer carton/expiry date indicates LOT #13650, EXP 06/2017.

  • Brand
    Apace KY LLC
  • Product
    Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode
  • 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: “All product was shipped to KY and further distributed 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 6 months after the firm started it.

1. Firm started the recall: Feb 12, 201612. FDA classified it Class III: Apr 5, 201623. Published in FDA’s Enforcement Report: Apr 13, 201634. FDA terminated the recall: Aug 22, 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-0811-2016 (February 12, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0811-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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