CLASS II ONGOING Drug recall · Reported 16 Apr 2025 · FDA Enforcement Report
Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalled
Glenmark Pharmaceuticals Inc., U is recalling Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a), distributed nationwide in the US. The recall was initiated on 13 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0347-2025
- FDA event ID
- 96474
- Recalling firm
- Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
- Manufacturer
- GLENMARK THERAPEUTICS INC., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Mar 2025
- FDA classified
- 8 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 13 Mar 2025 | Recall initiated by company | |
| 8 Apr 2025 | Classified by FDA | +26 days |
| 16 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalled?
Yes. Glenmark Pharmaceuticals Inc., U recalled Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) on 13 Mar 2025. The recall is Class II and its status is Ongoing. Recall number D-0347-2025.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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