Acetaminophen and Ibuprofen (NSAID) Tablets recall
FDA recall D-0347-2025 · initiated Mar 13, 2025
Glenmark Pharmaceuticals Inc., USA recalled Acetaminophen and Ibuprofen (NSAID) Tablets in Mar 2025 — an FDA Class II recall (D-0347-2025) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Mar 13, 2025
- FDA report date
- Apr 16, 2025
This recall is linked to a product we cover: Acetaminophen and Ibuprofen →
Frequently asked
- Was Acetaminophen and Ibuprofen (NSAID) Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Acetaminophen and Ibuprofen (NSAID) Tablets in Mar 2025 — an FDA Class II recall (D-0347-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Acetaminophen and Ibuprofen (NSAID) Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0347-2025 was: CGMP Deviations
- Is a recalled Acetaminophen and Ibuprofen (NSAID) Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acetaminophen and Ibuprofen (NSAID) Tablets are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0347-2025.