Lac-Hydrin — Class III drug recall D-163-2013
Terminated recall by Ranbaxy Inc., reported 2013-02-20, distributed nationwide. Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due
| Recall number | D-163-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ranbaxy Inc., Princeton, NJ, United States |
| Recall initiated | 2012-12-27 |
| Classified | 2013-02-12 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2014-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 6,535 tubes |
| NDC | 10631-0099-28, 10631-0099-38 |
| Lot numbers | 07/13, 07/14, RB91881, RB91891 |
Product
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
Reason for recall
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
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-163-2013. 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.