Aspirin Chewable tablet 81 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT SKU 913724 BAYER BACK BODY EX STRGTH CAPLETS 24CT SKU 900438 BAYER LOW DOSE 81 MG TABLET 120 CT SKU 916070 BAYER ASPIRIN 325MG TABLET 24CT SKU 913996 BAYER LOW DOSE TABLET 32CT SKU 915641 BAYER 81MG CHEWABLE TABLET 36 CT SKU 916078 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Drug: Aspirin Category: Pain Relief & OTC Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Failed Tablet/Capsule Specification : Capsule breakage
CGMP Deviations
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.