Aurobindo Pharma USA Inc. is voluntarily recalling 112,932 bottles of Amazon-branded Extra Strength Acetaminophen 500mg caplets after consumers reported that tablets appeared discolored. The recall was announced October 2026 and is listed as ongoing by the FDA with no risk classification yet assigned. No adverse health events have been reported. The affected product was distributed nationwide in three bottle sizes: 200-count, 500-count, and 1,000-count containers.
What’s Being Recalled?
Seven specific lots across three bottle sizes are included. The lot number and expiration date are printed on the bottle:
200-count bottles — Lot ACD125040A, expiration 09/30/2027
500-count bottles — Lot ACD124036A, expiration 09/30/2027; Lot ACD124030A, expiration 09/30/2027; Lot ACD124042A, expiration 10/31/2027; Lot ACD124048B, expiration 11/30/2027; Lot ACD125010A, expiration 02/29/2028
1,000-count bottles — Lot ACD124048A, expiration 11/30/2027
Note: Lots ACD124048B (500-count) and ACD124048A (1,000-count) share the same expiration date but differ in their final letter — be sure to match both the lot number and bottle size. The expiration date alone is not enough to identify a recalled bottle.
Why Was This Product Recalled?
Consumers reported the acetaminophen caplets appeared discolored. The FDA enforcement report does not specify what caused the discoloration or establish the precise health risk, and no risk classification has been assigned. Discolored tablets can indicate degradation, contamination, or manufacturing inconsistency. While the FDA has not confirmed that the recalled tablets are harmful, the recall allows consumers to exchange affected product for unaffected bottles.
What Should You Do?
Check your medicine cabinet for Amazon Extra Strength Acetaminophen 500mg bottles matching any of the lot numbers and bottle sizes listed above. Do not discard the medication without first checking whether your specific lot is included. Return the recalled bottles to Amazon or the place of purchase for a full refund. The FDA enforcement report is available at fda.gov for the complete listing.
Source: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99934
