CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Alka-Seltzer Original ( 325 mg Aspirin (Nsaid) recalled
Bayer HealthCare Pharmaceuticals is recalling Alka-Seltzer Original ( 325 mg Aspirin (Nsaid), 1916 mg Analgesic, Sodium, distributed nationwide in the US. The recall was initiated on 30 Mar 2017 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-1044-2017
- FDA event ID
- 77484
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Morristown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2017
- FDA classified
- 1 Aug 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 30 Mar 2017 | Recall initiated by company | |
| 1 Aug 2017 | Classified by FDA | +124 days |
| 9 Aug 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Product as listed by the FDA
Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Which lots are affected?
BTAH340; Exp. 02/19 BTAHCP0; Exp. 04/19 BTAHLW0; Exp. 06/19 BTAHLX0; Exp. 08/19 BTAHP10; Exp 08/19
Where was it sold?
Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 77484| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Alka-Seltzer Gold (1000 mg Anhydrous citric acid recalled | Bayer HealthCare Pharmaceuticals | Other | Nationwide | |
| CLASS II | Alka-Seltzer Extra Strength (500 mg Aspirin (Nsaid) recalled | Bayer HealthCare Pharmaceuticals | Other | Nationwide |
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