Pain Reliever Caplets Recalled Due to Out-of-Specification Impurity
Aurobindo Pharma is recalling 87,360 bottles of Pain Reliever Acetaminophen caplets (500 mg) distributed nationwide through Walgreens due to failed impurity specifications discovered through customer complaints about discoloration.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with an out-of-specification impurity and no reported illnesses or injuries. Per the rubric, theoretical hazards without reported harm are at most score 3.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Pain Reliever Acetaminophen caplets (500 mg, 225-count bottles) due to failed impurity and degradation specifications. The product was found to be out of specification for an impurity, which was discovered during the company's investigation following customer complaints about discoloration.
The recalled product was distributed nationwide in the USA through Walgreens. The affected lots are P2200101, P2200178 (expiring November 2023), and P2200230 (expiring December 2023). A total of 87,360 bottles were distributed.
Consumers with the recalled product should discontinue use. Those with questions or concerns should contact Aurobindo Pharma USA Inc. or their healthcare provider.
The recalled product
- Product
- PAIN RELIEVER (ACETAMINOPHEN)
- Brand
- PAIN RELIEVER
- Manufacturer
- Aurobindo Pharma USA Inc.
- Affected units
- 87,360
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 (5)
- Lot: P2200101
- P2200178
- Exp. date 11/2023
- P2200230
- Exp. date 12/2023
Distribution
Distributed nationwide across the United States.
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