Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Product description
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Lot numbers, UPCs & expiration codes
Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/2026.
Where it was sold
Nationwide
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-0568-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 7, 2025
- FDA report date
- Aug 13, 2025
- Quantity
- 875 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0568-2025, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97251
- Address
- 94 Worldwide Dr
- Code information
- Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/2026.
- Postal code
- 30534-6828
- Report date
- Aug 13, 2025
- Product type
- Drugs
- Recall number
- D-0568-2025
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 875 bottles
- Reason for recall
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 4, 2025