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Use caution Drug recall · FDA · Published July 21, 2016

Arbor Pharmaceuticals recalls Cetylev tablets due to swelling risk

Arbor Pharmaceuticals recalls Cetylev (acetylcysteine) effervescent tablets for oral solution. Defective packaging may cause tablets to swell and enlarge, leading to potential choking or injury.

🇺🇸 FDA recall #D-0105-2017DrugArbor Pharmaceuticals ›
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Recalling firmArbor Pharmaceuticals Inc.6 Concourse Pkwy, Suite 1800 · Atlanta, GA 30328-6117
✎ GovInfoNow plain-language explainer

What happened, in plain English

Arbor Pharmaceuticals is recalling Cetylev (acetylcysteine) effervescent tablets for oral solution. The tablets may swell and enlarge due to a defective blister pack seal, which could cause choking or injury if swallowed. Read more at govinfonow.com/recall/42539-arbor-pharmaceuticals-recalls-cetylev-tablets-due-to-swelling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/42539-arbor-pharmaceuticals-recalls-cetylev-tablets-due-to-swelling-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0105-2017

Cite this page

“Arbor Pharmaceuticals recalls Cetylev tablets due to swelling risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42539-arbor-pharmaceuticals-recalls-cetylev-tablets-due-to-swelling-risk. Based on FDA recall #D-0105-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0105-2017%22&limit=1).

Why it’s dangerous

The blister packaging seal is incomplete, allowing oxygen and moisture to enter. This causes the tablets to swell and enlarge through the effervescence process, which could lead to choking or injury if swallowed.

Who’s affected

People who have the recalled Cetylev tablets (500 mg, Rx Only, 20 tablets per carton) are affected. Those who have taken the tablets recently or plan to use them are at risk of choking or injury.

How to tell if you have this one

Check for Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton. The lot numbers 005C16, 006C16, 007C16 (expiring 02/2018) are affected.

  • Brand
    Arbor Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check for Swelling

    Inspect the tablets for swelling or enlargement in the blister pack.

  2. Discard if Swollen

    If the tablets are swollen, discard them immediately and contact Arbor Pharmaceuticals for a replacement.

Where it went and when

Where it was distributed

Distributed in 14 states.

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: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Georgia, Louisiana, Mississippi, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia.

Recall timeline

FDA terminated this recall 6 months after the firm started it.

1. Firm started the recall: Jul 21, 201612. FDA classified it Class I: Oct 14, 201623. Published in FDA’s Enforcement Report: Oct 26, 201634. FDA terminated the recall: Jan 23, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class I
  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-0105-2017 (July 21, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0105-2017 to see it in context.
  • Plain-language summary written by qwen3:4b 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