Recall Weekly
Moderate riskFDA DrugClass II

Tychasis Coats Aloe Creme recalled for failed stability testing

Testing found that some batches of Tychasis Coats Aloe Creme (Allantoin 0.5%) did not meet the product's stability specifications for viscosity and appearance. The recall covers 4 oz and 16 oz jars distributed only in Texas, about 12,028 jars in total. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using jars from the affected lots.
  2. Check the lot number and expiration date. The 4 oz jars (NDC 70211-703-04) are lots 0002011787 and 0001932354. The 16 oz jars (NDC 70211-703-16) are lot 0002049590. All expire Apr-30-2027.
  3. The notice does not say how to get a refund or replacement. Contact Tychasis Corporation or the store where you bought the cream.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Tychasis Coats Aloe Creme (Allantoin 0.5%), packaged in a) 4oz (NDC 70211-703-04), and b)16 oz (NDC 70211-703-16) jars, Manufactured for: Tychasis Corporation, Dallas, TX 75227.
Sold in
TX only
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
12,028 jars
Illnesses reported
None reported
Manufactured in
8181 Eastpoint Dr Ste 100-500, Dallas, Texas, United States
Classification
Class II
Recall number
D-0160-2027

In the FDA's words

Description
Tychasis Coats Aloe Creme (Allantoin 0.5%), packaged in a) 4oz (NDC 70211-703-04), and b)16 oz (NDC 70211-703-16) jars, Manufactured for: Tychasis Corporation, Dallas, TX 75227. Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications. Lot #: a)0002011787,0001932354, Exp. Date Apr-30-2027; b) 0002049590, Exp. Date Apr-30-2027 Distribution: TX only Affected quantity: 12,028 jars
Hazard
Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications.

3 products in this recall

Tychasis Coats aloe products recalled for failed stability tests

BioMed Laboratories is recalling three Tychasis Coats products: aloe lotion (allantoin 0.5%), aloe creme (allantoin 0.5%) and aloe liniment (methyl salicylate 10%), in several bottle and jar sizes. The FDA reports that stability test results for viscosity and appearance did not align with the established specifications. The products were distributed in Texas only, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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