Drug recall: amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410…
Not yet classified FDA enforcement event 99934. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Discoloration: consumer complaints received for discolored tablets
Aurobindo Pharma USA Inc started this drug recall on 18 Sep 2026. The firm address in the FDA record is in East Windsor, NJ. The FDA record has no class for this recall. FDA event 99934 has 1 product record. The first FDA enforcement report date is 7 Oct 2026. The record gives the status Ongoing. 72 of the 258 drug events that started in 2026 have more product records. The median drug event of 2026 has 1 product record.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide.
Recalling firm
Aurobindo Pharma USA Inc, East Windsor, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Not yet classified: The enforcement report lists the recall, and FDA has not given it a class.
The event in context
- Drug events that started in 2026
- 258
- Share of these events with no class
- 1%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 34
Other events of the firm
Official channels
- FDA enforcement report The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99934. https://recallregister.com/fda/unclassified/99934/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide.
- What quantity of product is in FDA event 99934?
- The FDA record gives this quantity:
7,836 1000-count bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2026 have the same class?
- 1% of the 258 drug events that started in 2026 have no class.