CLASS I Drug recall · Reported 26 Oct 2016 · FDA Enforcement Report
Cetylev (acetylcysteine) effervescent tablets recalled
Arbor Pharmaceuticals is recalling Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, distributed in 14 states. The recall was initiated on 21 Jul 2016 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0105-2017
- FDA event ID
- 74857
- Recalling firm
- Arbor Pharmaceuticals, Atlanta, GA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Jul 2016
- FDA classified
- 14 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
Timeline
| 21 Jul 2016 | Recall initiated by company | |
| 14 Oct 2016 | Classified by FDA | +85 days |
| 26 Oct 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10.
Where it was distributed
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
CaliforniaFloridaGeorgiaLouisianaMissouriMississippiNorth CarolinaOhioPennsylvaniaSouth CarolinaTennesseeTexasVirginiaWest Virginia
Questions about this recall
Why was it recalled?
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Which lots are affected?
Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018
Where was it sold?
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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