Tychasis Coats aloe lotion recalled for failed stability tests
Stability testing found that some bottles of Tychasis Coats Aloe Lotion (Allantoin 0.5%) had viscosity and appearance results outside the established specifications. The recall covers 13,128 bottles distributed only in Texas. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Stop using the affected lots listed below.
- Check the 0.5 oz bottle for lot 011636 (exp. Nov-30-2026). Check the 8 oz bottles (NDC 70211-704-08) for lots 0001882604 (exp. Aug-31-2027), 0001987649 (exp. Apr-30-2028), and 008943 (exp. Nov-30-2026). Check the 33 oz bottle (NDC 70211-704-33) for lot 0001893936 (exp. Aug-31-2027).
- The 0.5 oz sample size has no NDC because it is used as a professional sample.
- The notice doesn't say how to get a refund or replacement; ask Tychasis Corporation or where you bought it.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Tychasis Coats Aloe Lotion (Allantoin 0.5%) packaged in a)0.5 oz, b)8 oz (NDC 70211-704-08), and c)33 oz (NDC 70211-704-33) bottles, Manufactured for: Tychasis Corporation, Dallas, TX 75227. There is no NDC for the 0.5 oz given that it is a sample size used as a professional sample.
- Sold in
- TX only
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 13,128 bottles
- Illnesses reported
- None reported
- Manufactured in
- 8181 Eastpoint Dr Ste 100-500, Dallas, Texas, United States
- Classification
- Class II
- Recall number
- D-0159-2027
In the FDA's words
- Description
- Tychasis Coats Aloe Lotion (Allantoin 0.5%) packaged in a)0.5 oz, b)8 oz (NDC 70211-704-08), and c)33 oz (NDC 70211-704-33) bottles, Manufactured for: Tychasis Corporation, Dallas, TX 75227. There is no NDC for the 0.5 oz given that it is a sample size used as a professional sample. Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications. Lot #:a) 011636, Exp. Date Nov-30-2026; b) 0001882604, Exp. Date Aug-31-2027; 0001987649, Exp. Date Apr-30-2028; 008943, Exp. Date Nov-30-2026; c) 0001893936, Exp. Date Aug-31-2027 Distribution: TX only Affected quantity: 13,128 bottles
- 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.
- Tychasis Coats Aloe Lotion (Allantoin 0.5%) packaged in a)0.5 oz, b)8 oz (NDC 70211-704-08), and c)33 oz (NDC 70211-704-33) bottles, Manufactured for: Tychas… (this page)D-0159-2027 · 13,128 bottles
- 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 Corporatio…D-0160-2027 · 12,028 jars
- Tychasis Coats Aloe Liniment (Methyl salicylate 10%), packaged a) 0.5 oz, b) 8 oz (NDC 70211-704-08) c) 33oz (NDC 70211-704-33) bottles, Manufactured for: Ty…D-0161-2027 · 11,130 bottles