CLASS III Drug recall · Reported 5 Mar 2014 · FDA Enforcement Report
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in sachet recalled
Actavis is recalling Gelnique (oxybutynin chloride) Gel 10%, 100 mg in sachet, for topical use only, distributed nationwide in the US. The recall was initiated on 7 Feb 2014 and the FDA has classified it as Class III.
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-1088-2014
- FDA event ID
- 67457
- Recalling firm
- Actavis, Salt Lake City, UT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Feb 2014
- FDA classified
- 25 Feb 2014
- Reported
- 5 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Bladder & Prostate Medication
Timeline
| 7 Feb 2014 | Recall initiated by company | |
| 25 Feb 2014 | Classified by FDA | +18 days |
| 5 Mar 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Drug potency was compromised during shipment.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.
Where it was distributed
Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
Questions about this recall
Why was it recalled?
Subpotent Drug: Drug potency was compromised during shipment.
Which lots are affected?
Lot #: 514656; Expiry: 03/14
Where was it sold?
Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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