Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Lot numbers, UPCs & expiration codes
Lot #: A240211, Exp. Date April 2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0169-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 16, 2024
- FDA report date
- Jan 8, 2025
- Quantity
- 5,870 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SOMERSET THERAPEUTICS LLC
Original FDA data
Every field from FDA enforcement report D-0169-2025, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 95997
- Address
- 300 Franklin Square Dr
- Code information
- Lot #: A240211, Exp. Date April 2026
- Postal code
- 08873-4187
- Report date
- Jan 8, 2025
- Product type
- Drugs
- Recall number
- D-0169-2025
- Classification
- Class III
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Product quantity
- 5,870 bottles
- Termination date
- Jun 10, 2025
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 16, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 31, 2024