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
AvKARE Recalls Norgestimate and Ethinyl Estradiol Tablets Due to Hazard
AvKARE recalled 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets on September 2, 2025. The tablets failed content uniformity specifications, posing a high hazard risk. Consumers should stop using the product immediately and consult their healthcare provider.
Quick Facts at a Glance
- Recall Date
- September 2, 2025
- Hazard Level
- HIGH
- Brand
- AvKARE
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
Hazard Information
Failed Content Uniformity Specifications
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: Letter
Product Details
The recalled products include Norgestimate and Ethinyl Estradiol Tablets, USP, in three strengths: 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg. They were distributed nationwide in the U.S. The affected lot number is LF41138A, with an expiration date of June 30, 2027.
The Hazard
The recall stems from a failure to meet content uniformity specifications. This failure can result in inconsistent dosing, leading to potential health risks.
Reported Incidents
No specific incidents, injuries, or deaths have been reported in connection with this recall. The risk remains high due to the nature of the dosage inconsistency.
What to Do
Consumers should stop using the recalled tablets immediately. Contact AvKARE or your healthcare provider for guidance and further information.
Contact Information
For more information, call AvKARE at 1-800-XXXX-XXXX. Additional details can be found at the FDA's recall page.
Key Facts
- Recall date: September 2, 2025
- Quantity recalled: 2,192 cartons
- Affected lot: LF41138A
- Expiration date: June 30, 2027
- High hazard risk due to dosage inconsistency
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Safety Assessment
Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeNorgestimate and Ethinyl Estradiol Tablets
Sold At
Multiple Retailers
Product Details
Brand
Model Numbers
Lot # LF41138A
Exp 06/30/2027
UPC Codes
42291-565
42291-565-28
42291-565-84
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
Related Recalls
HIGH
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