Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch: a) 16293, Exp. 1/31/2023; 16436, 16451, Exp. 2/28/2023; b) 15105, Exp. 2/28/2022; 15290, 15291, 15292, Exp. 3/31/2022; 16293, Exp. 1/31/2023; 16436, 16451, 16472, Exp. 2/28/2023
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teligent Pharma, Inc.
- Reason for Recall:
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Product Codes/Lot Numbers:
Batch: a) 16293, Exp. 1/31/2023; 16436, 16451, Exp. 2/28/2023; b) 15105, Exp. 2/28/2022; 15290, 15291, 15292, Exp. 3/31/2022; 16293, Exp. 1/31/2023; 16436, 16451, 16472, Exp. 2/28/2023
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0692-2022
Related Recalls
Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
Teligent Pharma
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.