FDA Recalls Indomethacin Extended-Release Capsules for Manufacturing Deviations
Amerisource Health Services is recalling 21 cartons of Indomethacin Extended-Release Capsules due to manufacturing deviations. Patients should consult their pharmacist before using this prescription medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription drug with no reported illnesses or hospitalizations. While Class II recalls indicate a potential for adverse health consequences, the source provides no evidence of actual harm. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Amerisource Health Services LLC is recalling Indomethacin Extended-Release Capsules, USP, 75 mg due to manufacturing deviations. The affected product is distributed in cartons containing 30 capsules (three 10-count blister cards per carton). This recall affects 21 cartons with Lot #1021950 (expiration date November 30, 2026) that were distributed nationwide in the United States.
The recall was initiated due to violations of current good manufacturing practices (cGMP). These are manufacturing and quality-control standards mandated by the FDA to ensure drug safety and quality. The company voluntarily initiated this recall and notified the FDA, which classified it as a Class II recall.
Patients currently taking this medication should contact their pharmacist or physician before continuing use. Provide your pharmacy with the lot number (1021950) and expiration date (11/30/2026) to determine if your medication is affected. If you have questions about the safety of your medication, do not discontinue use without consulting your healthcare provider.
The recalled product
- Product
- INDOMETHACIN (INDOMETHACIN)
- Brand
- INDOMETHACIN
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1021950
- Exp. 11/30/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · INDOMETHACIN
- ModerateIndomethacin Extended-Release Capsules Voluntarily Recalled for Manufacturing Deviations
FDA (Drugs) · 2025-05-28
- ModerateGlenmark Pharmaceuticals Recalls Indomethacin Capsules for Manufacturing Deviations
FDA (Drugs) · 2025-04-16
- ModerateIndomethacin Extended-Release Capsules Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2024-09-04
- HighPrescription Drug Indomethacin Recalled Due to Label Mix-Up
FDA (Drugs) · 2023-12-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27