FDA Drug recall D-162-2013
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14
- FDA Drug
- Class III
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class III recall of Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14 by Ranbaxy, citing crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-162-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-27 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ranbaxy |
| Distribution | US |
Product
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
Reason
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Identifiers
| code_info | Lot #: RB93911, Exp 07/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Ranbaxy
- Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only
FDA Drug · Class II · 2015-08-12 · Ranbaxy - Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL…
FDA Drug · Class II · 2014-03-05 · Ranbaxy - Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28
FDA Drug · Class III · 2013-02-20 · Ranbaxy - Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceutical…
FDA Drug · Class II · 2012-12-05 · Ranbaxy - Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257…
FDA Drug · Class II · 2012-12-05 · Ranbaxy
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-162-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.