OTC Acetaminophen and Ibuprofen Tablets Recalled for Manufacturing Quality Deviations
Glenmark Pharmaceuticals is recalling acetaminophen-ibuprofen tablets due to manufacturing quality deviations. No illnesses reported. Distributed nationwide via Amazon and Walmart.
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 product is classified as FDA Class II, indicating potential for adverse health consequences from manufacturing deviations. However, no illnesses or injuries have been reported. Per the rubric, theoretical hazards without reported harm are capped at High severity.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling specific lots of acetaminophen and ibuprofen combination tablets (250 mg acetaminophen / 125 mg ibuprofen). The recalled products are 144-count packets (NDC 72657-157-74) and 216-count packets (NDC 72657-157-76).
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The affected lots (17241302, 17241140, and 17241141) with expiration date July 2026 were distributed nationwide through Amazon and Walmart. No illnesses or adverse events related to this product have been reported.
Consumers with affected packets should stop using them and contact Glenmark Pharmaceuticals or their retailer for instructions on return or disposal. The product is distributed by Glenmark Therapeutics Inc. from Mahwah, New Jersey.
The recalled product
- Product
- ACETAMINOPHEN, IBUPROFEN (ACETAMINOPHEN, IBUPROFEN)
- Brand
- ACETAMINOPHEN, IBUPROFEN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — OTC Pain Relief
- Hazard
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 (4)
- Lot # 17241302
- exp. date Jul-26 Amazon & Walmart 17241140
- exp. date Jul-26 Amazon & Walmart 17241141
- exp. date Jul-26 Amazon & Walmart
UPCs (1)
- 0372657157742
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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