Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported February 20, 2013
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.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Ranbaxy Inc. recalled Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 106… - a low-severity action.
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 106… was recalled by Ranbaxy Inc. in February 20, 2013. Reason: Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely du…. Check the official notice for the remedy. Verify recall #D-163-2013 with the FDA Drug before acting.
The recall
Ranbaxy Inc. issued this low-severity FDA Drug recall-Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely du….
- Low
- severity level
- Class III
- classification
- February 20, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-163-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-163-2013) was formally reported on February 20, 2013, with the manufacturer initiating the action on December 27, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Ranbaxy Inc. is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 6,535 tubes and bottles.
The documented reason for this recall is: Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6,535 tubes and bottles
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-163-2013 |
| Date reported | February 20, 2013 |
| Date initiated | December 27, 2012 |
| Recalling firm | Ranbaxy Inc. |
| Firm location | Princeton, NJ |
| Affected scope | 6,535 tubes and bottles |
| Distribution | Nationwide and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-163-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ranbaxy Inc.. Units affected: 6,535 tubes and bottles.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2013. Severity: Low. Recall number: D-163-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-163-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.