CLASS III Drug recall · Reported 20 Feb 2013 · FDA Enforcement Report
Lac-Hydrin (ammonium lactate) Cream recalled by Ranbaxy
Ranbaxy is recalling Lac-Hydrin (ammonium lactate) Cream, 12%, distributed nationwide in the US. The recall was initiated on 27 Dec 2012 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-163-2013
- FDA event ID
- 64286
- Recalling firm
- Ranbaxy, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Dec 2012
- FDA classified
- 12 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 27 Dec 2012 | Recall initiated by company | |
| 12 Feb 2013 | Classified by FDA | +47 days |
| 20 Feb 2013 | 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
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
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
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Which lots are affected?
Lot #: RB91881, Exp 07/14; RB91891, Exp 07/13
Where was it sold?
Nationwide and Puerto Rico
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.
Other products in this recall event
1 other product · FDA event 64286This product is part of a recall event; the main page for the event is Lac-Hydrin (ammonium lactate) Lotion recalled by Ranbaxy.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Lac-Hydrin (ammonium lactate) Lotion recalled by Ranbaxy | Ranbaxy | Packaging Defects | Nationwide |
More recalls from Ranbaxy
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Absorica (isotretinoin) Capsules, 25 mg recalled by RanbaxyAbsorica Ld | Ranbaxy | Labeling Errors | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets recalled by RanbaxyAtorvastatin Calcium | Ranbaxy | Packaging Defects | Nationwide |
| Drug | CLASS III | Lac-Hydrin (ammonium lactate) Lotion recalled by Ranbaxy | Ranbaxy | Packaging Defects | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, 40 mg, a) per, b) recalled by RanbaxyAtorvastatin Calcium | Ranbaxy | Particulate Matter | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, 20 mg recalled by RanbaxyAtorvastatin Calcium | Ranbaxy | Particulate Matter | Nationwide |
Other Lac-hydrin (ammonium Lactate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lac-Hydrin (ammonium lactate) Lotion recalled by Ranbaxy | Ranbaxy | Packaging Defects | Nationwide |