HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by:...
Failed Impurities/Degradation Specifications
Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brands
- VIORELE, Glenmark Pharmaceuticals Inc., USA
- Geographic Scope
- 1 states
Hazard Information
Failed Impurities/Degradation Specifications
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
Full Description
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.. Generic: DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL; Brand: VIORELE. Reason: Failed Impurities/Degradation Specifications. Classification: Class II. Quantity: 26,928 packs. Distribution: US Nationwide.
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Product Classification
Product Details
Model Numbers
Batch number 20230733
Exp Date: October 2025
UPC Codes
68462-318
68462-318-29
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
Related Recalls
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Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
SUCRALFATE
CGMP Deviations:
HIGH
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect