Aurobindo Pharma recalls over 4,600 bottles of painkiller in US market

The drug, Acetaminophen Tablets (325 mg), is being recalled due to manufacturing deviations from Current Good Manufacturing Practices, following complaints of brown tablet discolouration

Aurobindo Pharma’s United States unit has initiated a recall of more than 4,600 bottles of a pain relief medication from the American market following consumer complaints about product quality, according to the US Food and Drug Administration’s (USFDA) Enforcement Report.

 

The product — Acetaminophen Tablets (325 mg) — is being recalled due to manufacturing deviations from Current Good Manufacturing Practices (cGMP), triggered by “confirmed consumer complaints received with the observation of tablet discolouration (brown surface on tablets)”, the US drug regulator mentioned. 

 

The Class-II recall of the drug, which is generally used for the relief of headaches, migraine, back pain, toothache, and muscular pain, was initiated by the Princeton-based subsidiary on May 22, the report mentioned.

 

As per the USFDA classification, a Class-II recall is initiated “when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the probability of serious adverse health consequences is remote.”

 

Product description  Acetaminophen Tablets, 325 mg, 100-count bottles  Distributed by Amazon.com Services LLC, USA

 

 

Reason for recall

 

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)

 

Product quantity

 

4,608 bottles

 

Classification

Class-II

 

Aurobindo Pharma Q4 results

In the fourth quarter of financial year 2024–25 (Q4FY25), Aurobindo Pharma Limited reported a marginal slump of 0.5 per cent in its net profit to ₹903 crore, compared to ₹907 crore in the same period last year.

 

However, the revenue from operations hiked 10.6 per cent year-on-year (Y-o-Y) to ₹8,382 crore during the quarter, with growth seen across key business segments.

 

Revenue from US formulations grew by 13.5 per cent Y-o-Y to ₹4,072 crore ($470 million), while Europe formulations posted a stronger growth of 17.2 per cent Y-o-Y to ₹2,147 crore (€236 million).  Shares of Aurobindo Pharma last traded at ₹1124.75 apiece on the BSE at the close of the markets on Friday.