Extra Strength Acetaminophen 500 MG Tablets recall
FDA recall D-0566-2024 · initiated May 20, 2024
Contract Pharmacal Corporation recalled Extra Strength Acetaminophen 500 MG Tablets in May 2024 — an FDA Class II recall (D-0566-2024) because Discoloration: Brownish tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discoloration: Brownish tablets
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 14,616 bottles
Details
- Product
- Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606
- Recalling company
- Contract Pharmacal
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- MI
- Initiated
- May 20, 2024
- FDA report date
- Jul 3, 2024
Frequently asked
- Was Extra Strength Acetaminophen 500 MG Tablets recalled?
- Contract Pharmacal Corporation recalled Extra Strength Acetaminophen 500 MG Tablets in May 2024 — an FDA Class II recall (D-0566-2024) because Discoloration: Brownish tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Extra Strength Acetaminophen 500 MG Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0566-2024 was: Discoloration: Brownish tablets
- Is a recalled Extra Strength Acetaminophen 500 MG Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Extra Strength Acetaminophen 500 MG Tablets are affected?
- Distributed: MI. The recall covers these lots — Lot#: 368638; Exp. 05/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0566-2024.