Safety Alert: Class II: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
healthClass IIRecalled on Sep 17, 2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles
🔢 3,591 bottles
Sold At: Breckenridge Pharmaceutical, Inc.(AZ, IN, NJ)
Recall #: FDA-DRUG-D-0621-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot 240927C, Exp 04/30/2027
Get AI-Powered Summary
Premium members get instant insights to help you understand recalls faster
Instant 1-3 sentence summary
Quick action bullets
Clear guidance on what to do
Summary
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Breckenridge Pharmaceutical, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.