CLASS II Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report
Extra Strength Headache (acetaminophen 250 mg recalled
Medique Products is recalling Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0391-2022
- FDA event ID
- 89356
- Recalling firm
- Medique Products, Fort Myers, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2021
- FDA classified
- 20 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 6 Dec 2021 | Recall initiated by company | |
| 20 Jan 2022 | Classified by FDA | +45 days |
| 26 Jan 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Product as listed by the FDA
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets recalled?
Yes. Medique Products recalled Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets on 6 Dec 2021. The recall is Class II and its status is Terminated. Recall number D-0391-2022.
Why was it recalled?
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Which lots are affected?
Lots: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023; 6898 Exp. 02/2023; 6901 Exp. 02/2023; 7059 Exp. 05/2023; 7060 Exp. 05/2023; 7064 Exp. 06/2023; 7065 Exp. 06/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medique Products
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Medique Pain-Off (Acetaminophen 250 mg, Aspirin recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Physicians Care Extra Strength Pain Reliever [Acetaminophen recalled | Medique Products | Manufacturing (CGMP) Deviations | Nationwide |