Gelnique — Class III drug recall D-1088-2014
Terminated recall by Actavis, reported 2014-03-05, distributed nationwide. Subpotent Drug: Drug potency was compromised during shipment.
| Recall number | D-1088-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis, Salt Lake City, UT, United States |
| Recall initiated | 2014-02-07 |
| Classified | 2014-02-25 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 38,227 clamshells |
| Reason classes | potency |
| NDC | 52544-0084-77 |
| Lot numbers | 03/14, 514656 |
Product
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.
Reason for recall
Subpotent Drug: Drug potency was compromised during shipment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1088-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.